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| ID | Type | Description | Link |
|---|---|---|---|
| C4251001 | Other Identifier | Alias Study Number | |
| 2024-514733-38-00 | Registry Identifier | CTIS (EU) |
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This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery.
Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer.
Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.
This study is designed to evaluate the efficacy and safety of tucatinib in combination with T-DM1 in participants with unresectable locally-advanced or metastatic HER2+ breast cancer who have had prior treatment with a taxane and trastuzumab in any setting. Prior pertuzumab treatment is permitted, but not required. Participants will be randomized in a 1:1 manner to receive 21-day cycles of either tucatinib or placebo in combination with T-DM1.
While on study treatment, participants will be assessed for progression every 6 weeks for the first 24 weeks, and every 9 weeks thereafter, irrespective of dose holds or interruptions. Study treatment will continue until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. After completion of study treatment and after occurrence of disease progression, participants in both arms of the study will continue to be followed for survival until study closure or withdrawal of consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tucatinib + T-DM1 | Experimental | Tucatinib + T-DM1 |
|
| Placebo + T-DM1 | Active Comparator | Placebo + T-DM1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tucatinib | Drug | 300mg given twice per day by mouth (orally) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 Based on Investigator Assessment | PFS as per investigator was defined as the time from the date of randomization to the investigator assessment of disease progression (PD) as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimiter (mm). Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. | From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from randomization to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact). | Up to approximately 5 years |
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Inclusion Criteria:
Histologically confirmed HER2+ breast carcinoma as determined by a sponsor-designated central laboratory
History of prior treatment with a taxane and trastuzumab in any setting, separately or in combination
Have progression of unresectable locally advanced/metastatic breast cancer after last systemic therapy, or be intolerant of last systemic therapy
Measurable or non-measurable disease assessable by RECIST v1.1
ECOG performance status score of 0 or 1
CNS Inclusion - Based on screening contrast brain magnetic resonance imaging (MRI), participants must have at least one of the following:
(a) No evidence of brain metastases
(b) Untreated brain metastases not needing immediate local therapy
(c) Previously treated brain metastases
Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy
Participants treated with CNS local therapy for newly identified lesions or previously treated and progressing lesions may be eligible to enroll if all of the following criteria are met:
(i) Time since SRS is at least 7 days prior to first dose of study treatment, time since WBRT is at least 14 days prior to first dose, or time since surgical resection is at least 28 days.
(ii) Other sites of evaluable disease are present
Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions
Exclusion Criteria:
Prior treatment with tucatinib, afatinib, trastuzumab deruxtecan (DS-8201a), or any other investigational anti-HER2, anti-EGFR, or HER2 TKI agent. Prior treatment with lapatinib or neratinib within 12 months of starting study treatment (except in cases where they were given for ≤21 days and was discontinued for reasons other than disease progression or severe toxicity). Prior treatment with pyrotinib for recurrent of mBC (except in cases where pyrotinib was given for ≤21 days and was discontinued for reasons other than disease progression or severe toxicity).
CNS Exclusion - Based on screening contrast brain magnetic resonance imaging (MRI), participants must not have any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama Health Children's and Women's Hospital | Mobile | Alabama | 36604 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41260264 | Derived | Hurvitz SA, Loi S, O'Shaughnessy J, Okines AFC, Tolaney SM, Sohn J, Saura C, Zhu X, Cameron D, Bachelot T, Hamilton E, Curigliano G, Wolff AC, Harbeck N, Masuda N, Vahdat L, Zaman K, Valdes-Albini F, Block M, Pluard T, Tan TJ, Gawryletz C, Chan A, Bedard PL, Yerushalmi R, Xu B, Schmitt M, Xie D, Borges VF; HER2CLIMB-02 study investigators. Tucatinib and trastuzumab emtansine for patients with previously treated HER2-positive locally advanced and metastatic breast cancer: primary analysis of the randomized phase III trial HER2CLIMB-02. Ann Oncol. 2026 Mar;37(3):341-352. doi: 10.1016/j.annonc.2025.11.005. Epub 2025 Nov 17. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 618 participants were screened of which 152 failed screening and 466 participants were enrolled in the study.
Participants diagnosed with locally advanced (LA) or metastatic human epidermal growth factor receptor 2 positive (HER2+) breast cancer who received prior treatment with a taxane and trastuzumab in any setting, were evaluated for efficacy and safety of tucatinib in combination with ado-trastuzumab emtansine (T-DM1) in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tucatinib+ Ado-trastuzumab Emtansine | Participants with HER2+ LA/mBC were treated with tucatinib 300 mg orally twice a day (BID) and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 8, 2023 | Jun 24, 2024 |
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| placebo | Drug | Given twice per day orally |
|
| T-DM1 | Drug | 3.6 mg/kg given into the vein (IV; intravenously) every 21 days |
|
|
| Progression-Free Survival as Per RECIST v1.1 in Participants With Brain Metastases at Baseline Based on Investigator Assessment |
PFS as per investigator was defined as the time from the date of randomization to the investigator assessment of PD as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. PFS was analyzed in participants with presence or history of brain metastases. |
| From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 45 months) |
| Objective Response Rate (ORR) as Per RECIST v1.1 Based on Investigator Assessment | ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than (<)10 mm. PR: a greater than equal (>=) 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. ORR by investigator assessment is based on investigator response assessments. Two-sided 95% exact confidence interval, computed using the Clopper-Pearson method. | From the date of first CR or PR until the date of the first documentation of PD or death, whichever occurred first (maximum up to 43 months) |
| Overall Survival in Participants With Brain Metastases at Baseline | OS was defined as the time from randomization to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact). OS was analyzed in participants with presence or history of brain metastases. | Up to approximately 5 years |
| Progression-Free Survival as Per RECIST v1.1 Determined by Blinded Independent Committee Review (BICR) | PFS as per BICR was defined as the time from the date of randomization to the centrally-reviewed documented PD as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without documented progression of PD or death at the time of analysis were censored at the date of the last tumor assessment. | From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months) |
| Progression-Free Survival in Participants With Brain Metastases at Baseline as Per RECIST v1.1 Determined by BICR | PFS as per BICR was defined as the time from the date of randomization to the centrally-reviewed documented PD as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PFS was analyzed in participants with presence or history of brain metastases. | From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months) |
| Objective Response Rate as Per RECIST v1.1 Determined by BICR | ORR was defined as the percentage of participants with confirmed CR or PR according to RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR per BICR is based on BICR response assessments. | From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months) |
| Duration of Response (DOR) as Per RECIST v1.1 Based on Investigator Assessment | DOR was defined as the time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD as per RECIST v1.1 PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DOR per investigator was based on investigator response assessments. | Up to approximately 5 years |
| Duration of Response as Per RECIST v1.1 by BICR | DOR was defined as the time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD as per RECIST v1.1 PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DOR per BICR was based on BICR response assessments. | Up to approximately 5 years |
| Clinical Benefit Rate (CBR) Per RECIST v1.1 Based on Investigator Assessment | CBR was defined as the percentage of participants with stable disease (SD) or non-CR or non-PD >= 6 months or best response of CR or PR according to RECIST v1.1. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CBR was based on investigator assessment. | Up to approximately 5 years |
| Clinical Benefit Rate as Per RECIST v1.1 by BICR | CBR was defined as the percentage of participants with SD or non-CR or non-PD >= 6 months or best response of CR or PR according to RECIST v1.1. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CBR per BICR is based on BICR response assessments. | Up to approximately 5 years |
| Number of Participants With Treatment Emergent Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE was defined as AE that is newly occurred or worsened after the start of study treatment. | From start of treatment up to 30 days after the last study treatment (approximately 43 months) |
| University of South Alabama Mitchell Cancer Institute |
| Mobile |
| Alabama |
| 36604 |
| United States |
| University of South Alabama Health University Hospital | Mobile | Alabama | 36617 | United States |
| Banner Gateway Medical Center | Gilbert | Arizona | 85234 | United States |
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States |
| Western Regional Medical Center, LLC | Goodyear | Arizona | 85338 | United States |
| Arizona Oncology Associates, PC - HOPE. | Tucson | Arizona | 85704 | United States |
| Arizona Oncology Associates, PC - HOPE | Tucson | Arizona | 85704 | United States |
| Arizona Oncology Associates, PC - HOPE | Tucson | Arizona | 85711 | United States |
| UCLA Hematology/Oncology - Alhambra | Alhambra | California | 91801 | United States |
| Kaiser Permanente Medical Center Lab Drawing Station | Antioch | California | 94509 | United States |
| Kaiser Permanente Medical Center Lab Drawing Station | Antioch | California | 94531 | United States |
| UCLA Hematology/Oncology- Beverly Hills | Beverly Hills | California | 90212 | United States |
| UC Irvine Health Cancer Center - Newport | Costa Mesa | California | 92627 | United States |
| City of Hope Investigational Drug Services (IDS) | Duarte | California | 91010 | United States |
| City of Hope(City of Hope National Medical Center,City of Hope Medical Center) | Duarte | California | 91010 | United States |
| Kaiser Permanente Medical Center (Radiology) | Dublin | California | 94568 | United States |
| UCLA Hematology/Oncology - Encino | Encino | California | 91436 | United States |
| Kaiser Permanente Medical Center Lab Drawing Station | Fairfield | California | 94533 | United States |
| Kaiser Permanente Medical Center Lab Drawing Station | Gilroy | California | 95020 | United States |
| UCLA Hematology/Oncology- Irvine | Irvine | California | 92604 | United States |
| Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D. | Los Angeles | California | 90095 | United States |
| Regulatory Management only: TRIO-US Central Administration | Los Angeles | California | 90095 | United States |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States |
| UCLA Hematology/Oncology | Los Angeles | California | 90095 | United States |
| UCLA West Medical Pharmacy | Los Angeles | California | 90095 | United States |
| Kaiser Permanente Medical Center Lab Drawing Station | Martinez | California | 94553 | United States |
| Kaiser Permanente Medical Center Lab Drawing Station | Milpitas | California | 95035 | United States |
| Kaiser Permanente Medical Center Lab Drawing Station | Modesto | California | 95356 | United States |
| Kaiser Permanente Medical Center Lab Drawing Station | Mountain View | California | 94041 | United States |
| Kaiser Permanente Medical Center Lab Drawing Station | Napa | California | 94558 | United States |
| Kaiser Permanente Medical Center (clinic+DSL) | Oakland | California | 94611 | United States |
| Kaiser Permanente Medical Center (Radiology) | Oakland | California | 94611 | United States |
| Chao Family Comprehensive Cancer Center University of California Irvine | Orange | California | 92868 | United States |
| UC Irvine Medical Center Attn: Trisha Maris | Orange | California | 92868 | United States |
| UCI Medical Center - Chao Family Comprehensive Cancer Center | Orange | California | 92868 | United States |
| Kaiser Permanente Medical Center Lab Drawing Station | Pleasanton | California | 94588 | United States |
| UCLA Hematology/Oncology - Porter Ranch | Porter Ranch | California | 91326 | United States |
| Kaiser Permanente Medical Center Lab Drawing Station | Redwood City | California | 94063 | United States |
| Kaiser Permanente Medical Center (clinic+DSL) | Roseville | California | 95661 | United States |
| Kaiser Permanente Sacramento J Street Medical Center (clinic+DSL+Lab Drawing Station) | Sacramento | California | 95814 | United States |
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
| University of California Davis | Sacramento | California | 95817 | United States |
| Kaiser Permanente Medical Center (Radiology) | Sacramento | California | 95825 | United States |
| Zuckerberg San Francisco General Hospital | San Francisco | California | 94110 | United States |
| Kaiser Permanente Medical Center (clinic+DSL) | San Francisco | California | 94115 | United States |
| University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center. | San Francisco | California | 94158 | United States |
| Kaiser Permanente Mission Bay Medical Center Lab Drawing Station | San Francisco | California | 94518 | United States |
| Kaiser Permanente Medical Center Lab Drawing Station | San Jose | California | 95110 | United States |
| Kaiser Permanente Medical Center (clinic+DSL) | San Jose | California | 95119 | United States |
| Kaiser Permanente Medical Center (clinic+DSL) | San Leandro | California | 94577 | United States |
| UCLA Hematology/Oncology - San Luis Obispo | San Luis Obispo | California | 93401 | United States |
| Kaiser Permanente Medical Center (clinic+DSL) | Santa Clara | California | 95051 | United States |
| UCLA Hematology/Oncology - Santa Monica | Santa Monica | California | 90404 | United States |
| UCLA Hematology/Oncology Parkside | Santa Monica | California | 90404 | United States |
| Kaiser Permanente Medical Center (clinic+DSL) | South San Francisco | California | 94080 | United States |
| Torrance Memorial Physician Network - Cancer Care | Torrance | California | 90505 | United States |
| Torrance Memorial Physician Network-Cancer Care | Torrance | California | 90505 | United States |
| UCLA Torrance Oncology | Torrance | California | 90505 | United States |
| UCLA Hematology/Oncology - Santa Clarita | Valencia | California | 91355 | United States |
| Kaiser Permanente Medical Center (clinic+DSL) | Vallejo | California | 94589 | United States |
| UCLA Hematology/Oncology - Ventura | Ventura | California | 93003 | United States |
| Kaiser Permanente Medical Center (clinic+DSL) | Walnut Creek | California | 94596 | United States |
| Rocky Mountain Cancer Centers, LLP | Aurora | Colorado | 80012 | United States |
| Clinical and Translational Research Center (CTRC) | Aurora | Colorado | 80045 | United States |
| University of Colorado Hospital - Anschutz Cancer Pavilion(ACP) | Aurora | Colorado | 80045 | United States |
| University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) | Aurora | Colorado | 80045 | United States |
| University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) | Aurora | Colorado | 80045 | United States |
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Rocky Mountain Cancer Centers, LLP | Boulder | Colorado | 80303 | United States |
| Rocky Mountain Cancer Centers, LLP | Centennial | Colorado | 80112 | United States |
| Rocky Mountain Cancer Centers, LLP | Colorado Springs | Colorado | 80907 | United States |
| UCH-MHS Memorial Hospital Central | Colorado Springs | Colorado | 80909 | United States |
| Printers Park Medical Plaza | Colorado Springs | Colorado | 80910 | United States |
| Briargate Medical Campus | Colorado Springs | Colorado | 80920 | United States |
| UCH-MHS Memorial Hospital North | Colorado Springs | Colorado | 80920 | United States |
| UCHealth Cherry Creek Medical Center | Denver | Colorado | 80206 | United States |
| UCHealth IDS Research Pharmacy - Cherry Creek | Denver | Colorado | 80206 | United States |
| Cancer Centers of Colorado at Saint Joseph Hospital | Denver | Colorado | 80218 | United States |
| Rocky Mountain Cancer Centers, LLP | Denver | Colorado | 80218 | United States |
| SCL Health Saint Joseph Hospital | Denver | Colorado | 80218 | United States |
| Rocky Mountain Cancer Centers, LLP | Denver | Colorado | 80220 | United States |
| Poudre Valley Hospital | Fort Collins | Colorado | 80524 | United States |
| Cancer Care & Hematology - Fort Collins | Fort Collins | Colorado | 80528 | United States |
| Cancer Care & Hematology - Greeley | Greeley | Colorado | 80634 | United States |
| SCL Health Good Samaritan Medical Center Cancer Centers of Colorado | Lafayette | Colorado | 80026 | United States |
| SCL Health Good Samaritan Medical Center | Lafayette | Colorado | 80026 | United States |
| Rocky Mountain Cancer Centers, LLP | Lakewood | Colorado | 80228 | United States |
| Rocky Mountain Cancer Centers, LLP | Littleton | Colorado | 80120 | United States |
| Rocky Mountain Cancer Centre, LLP | Lone Tree | Colorado | 80124 | United States |
| Cancer Care & Hematology - Loveland | Loveland | Colorado | 80538 | United States |
| Rocky Mountain Cancer Centers, LLP | Thornton | Colorado | 80260 | United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Washington Cancer Institute at MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Florida Cancer Specialists | Altamonte Springs | Florida | 32701 | United States |
| Florida Cancer Specialists | Bonita Springs | Florida | 34135 | United States |
| Florida Cancer Specialists | Brandon | Florida | 33511 | United States |
| Florida Cancer Specialists | Cape Coral | Florida | 33909 | United States |
| Florida Cancer Specialists | Clearwater | Florida | 33761 | United States |
| Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center | Coral Gables | Florida | 33146 | United States |
| Florida Cancer Specialists. | Daytona Beach | Florida | 32117 | United States |
| Sylvester Comprehensive Cancer Center- Deerfield Beach | Deerfield Beach | Florida | 33442 | United States |
| Florida Cancer Specialists - South Region | Fort Myers | Florida | 33901 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33905 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33908 | United States |
| Florida Cancer Specialists | Gainesville | Florida | 32605 | United States |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | 32207 | United States |
| Florida Cancer Specialists | Largo | Florida | 33770 | United States |
| Florida Cancer Specialists | Lecanto | Florida | 34461 | United States |
| Bascom Palmer Eye Institute | Miami | Florida | 33136 | United States |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Miami Cancer Institute at Baptist Health, Inc. | Miami | Florida | 33176 | United States |
| Sylvester Comprehensive Cancer Center Kendall | Miami | Florida | 33176 | United States |
| Florida Cancer Specialists | Naples | Florida | 34102 | United States |
| Florida Cancer Specialists | Ocala | Florida | 34474 | United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| AdventHealth Hematology and Oncology | Orlando | Florida | 32804 | United States |
| AdventHealth Medical Group Orlando | Orlando | Florida | 32804 | United States |
| AdventHealth Orlando Infusion Center | Orlando | Florida | 32804 | United States |
| AdventHealth Orlando, Investigational Drug Services | Orlando | Florida | 32804 | United States |
| Florida Cancer Specialists | Orlando | Florida | 32806 | United States |
| Orlando Health, Inc. TRIO | Orlando | Florida | 32806 | United States |
| Sylvester Comprehensive Cancer Center Plantation | Plantation | Florida | 33324 | United States |
| Florida Cancer Specialists | Port Charlotte | Florida | 33980 | United States |
| Florida Cancer Specialists | Sarasota | Florida | 34236 | United States |
| Florida Cancer Specialists - North Region | St. Petersburg | Florida | 33705 | United States |
| Florida Cancer Specialists | St. Petersburg | Florida | 33705 | United States |
| Florida Cancer Specialists. | Stuart | Florida | 34994 | United States |
| Florida Cancer Specialists | Tampa | Florida | 33607 | United States |
| Moffitt Cancer Center, Richard M, Schulze Family Foundation Outpatient Center at McKinley Campus | Tampa | Florida | 33612 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Moffitt McKinley Hospital | Tampa | Florida | 33612 | United States |
| Florida Cancer Specialists | Tavares | Florida | 32778 | United States |
| Florida Cancer Specialists | The Villages | Florida | 32159 | United States |
| Florida Cancer Specialists | Trinity | Florida | 34655 | United States |
| Florida Cancer Specialists. | Vero Beach | Florida | 32960 | United States |
| Florida Cancer Specialists. | Wellington | Florida | 33414 | United States |
| Florida Cancer Specialists. | West Palm Beach | Florida | 33401 | United States |
| Northside Hospital, Inc. - GCS/ Athens | Athens | Georgia | 30606 | United States |
| Winship Cancer Institute, Emory University. | Atlanta | Georgia | 30322 | United States |
| Atlanta Cancer Care - Atlanta | Atlanta | Georgia | 30342 | United States |
| Northside Hospital, Inc. - Central Research Department | Atlanta | Georgia | 30342 | United States |
| Northside Hospital, Inc. - GCS/Northside | Atlanta | Georgia | 30342 | United States |
| Georgia Cancer Center at Augusta University | Augusta | Georgia | 30912 | United States |
| Northside Hospital, Inc. - GCS/Blairsville | Blairsville | Georgia | 30512 | United States |
| Northside Hospital, Inc. - GCS/Canton | Canton | Georgia | 30115 | United States |
| Atlanta Cancer Care - Cumming | Cumming | Georgia | 30041 | United States |
| Northside Hospital, Inc. - GCS/Macon | Macon | Georgia | 31217 | United States |
| Northside Hospital, Inc. - GCS/Kennestone | Marietta | Georgia | 30060 | United States |
| Hawai'i Pacific Health Research Institute - Administrative Site | Honolulu | Hawaii | 96813 | United States |
| Kaiser Permanente Hawaii. | Honolulu | Hawaii | 96819 | United States |
| Kaiser Permanente Hawaii | Honolulu | Hawaii | 96819 | United States |
| Kapi'olani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| Kapi'olani Women's Center | Honolulu | Hawaii | 96826 | United States |
| Illinois CancerCare- Bloomington | Bloomington | Illinois | 61704 | United States |
| Rush University Medical Center, Professional Office Building Infusion Pharmacy | Chicago | Illinois | 60612 | United States |
| Rush University Medical Center. | Chicago | Illinois | 60612 | United States |
| University of Chicago Medical Center, CCD- Investigational Drug Service Pharmacy | Chicago | Illinois | 60637 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Illinois CancerCare - Galesburg | Galesburg | Illinois | 61401 | United States |
| University of Chicago Comprehensive Cancer Center at Silver Cross Hospital | New Lenox | Illinois | 60451 | United States |
| Orland Park - University of Chicago Center for Advanced Care | Orland Park | Illinois | 60462 | United States |
| Illinois CancerCare- Pekin | Pekin | Illinois | 61554 | United States |
| Illinois CancerCare, P.C. | Peoria | Illinois | 61615 | United States |
| Illinois CancerCare- Peru | Peru | Illinois | 61354 | United States |
| Ft Wayne Medical Oncology and Hematology, Inc TRIO | Fort Wayne | Indiana | 46804 | United States |
| The University of Kansas Cancer Center - West | Kansas City | Kansas | 66112 | United States |
| MidAmerica Division, Inc. c/o Menorah Medical Center | Overland Park | Kansas | 66209 | United States |
| The University of Kansas Cancer Center - Overland Park | Overland Park | Kansas | 66210 | United States |
| The University of Kansas Cancer Center - Indian Creek Campus | Overland Park | Kansas | 66211 | United States |
| The University of Kansas Cancer Center Breast Surgery Center - Indian Creek Campus | Overland Park | Kansas | 66211 | United States |
| The University of Kansas Cancer Center, Investigational Drug Services | Westwood | Kansas | 66205 | United States |
| The University of Kansas Cancer Center | Westwood | Kansas | 66205 | United States |
| CHI Saint Joseph Cancer Care | Lexington | Kentucky | 40509 | United States |
| Saint Joseph Health Infusion Services | Lexington | Kentucky | 40509 | United States |
| University of Maryland, Greenebaum Comprehensive Cancer Center. | Baltimore | Maryland | 21201 | United States |
| Mercy Medical Center -Weinberg Center | Baltimore | Maryland | 21202 | United States |
| Mercy Medical Center. | Baltimore | Maryland | 21202 | United States |
| Maryland Oncology Hematology, P.A | Bethesda | Maryland | 20817 | United States |
| Maryland Oncology Hematology, P.A | Brandywine | Maryland | 20613 | United States |
| Maryland Oncology Hematology, P.A | Columbia | Maryland | 21044 | United States |
| Maryland Oncology Hematology, P.A | Frederick | Maryland | 21702 | United States |
| Maryland Oncology Hematology, P.A | Largo | Maryland | 20774 | United States |
| Maryland Oncology Hematology, P.A | Rockville | Maryland | 20850 | United States |
| Maryland Oncology Hematology, P.A | Silver Spring | Maryland | 20904 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute- Chestnut Hill | Newton | Massachusetts | 02459 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Brighton Center for Specialty Care | Brighton | Michigan | 48116 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Minnesota Oncology Hematology, P.A. | Edina | Minnesota | 55435 | United States |
| Siteman Cancer Center - St Peters | City of Saint Peters | Missouri | 63376 | United States |
| Siteman Cancer Center - West County | Creve Coeur | Missouri | 63141 | United States |
| Siteman Cancer Center - North County | Florissant | Missouri | 63031 | United States |
| MidAmerica Division, Inc. c/o Centerpoint Medical Center | Independence | Missouri | 64057 | United States |
| Saint Luke's Cancer institute | Kansas City | Missouri | 64111 | United States |
| Saint Luke's Hospital Investigational Pharmacy | Kansas City | Missouri | 64111 | United States |
| The University of Kansas Cancer Center | Kansas City | Missouri | 64116 | United States |
| MidAmerica Division, Inc., c/o Research Medical Center | Kansas City | Missouri | 64132 | United States |
| The University of Kansas Cancer Center -North | Kansas City | Missouri | 64154 | United States |
| The University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | 64064 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine - Siteman Cancer Center. | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine - St. Louis | St Louis | Missouri | 63110 | United States |
| Siteman Cancer Center - South County | St Louis | Missouri | 63129 | United States |
| St. Vincent Healthcare | Billings | Montana | 59101 | United States |
| St. Vincent - Frontier Cancer Center | Billings | Montana | 59102 | United States |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists | Omaha | Nebraska | 68114 | United States |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists | Omaha | Nebraska | 68124 | United States |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | United States |
| West Omaha Imaging | Omaha | Nebraska | 68130 | United States |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89052 | United States |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89074 | United States |
| Comprehensive Cancer Centers of Nevada Research Department | Henderson | Nevada | 89119 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89052 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89128 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89144 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89148 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| Summit Medical Group | Berkeley Heights | New Jersey | 07922 | United States |
| Summit Medical Group | Florham Park | New Jersey | 07932 | United States |
| Cooperman Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| New York Oncology Hematology, P.C. | Albany | New York | 12206 | United States |
| Stony Brook Advanced Imaging | Stony Brook | New York | 11794 | United States |
| Stony Brook Cancer Center | Stony Brook | New York | 11794 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| Carolinas Medical Center (biopsy only) | Charlotte | North Carolina | 28203 | United States |
| Charlotte Radiology Medical Center Plaza Breast Center (biopsy only) | Charlotte | North Carolina | 28203 | United States |
| Carolinas Medical Center Investigational Drug Services | Charlotte | North Carolina | 28204 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Carolinas Medical Center - Mercy (biopsy only) | Charlotte | North Carolina | 28207 | United States |
| Atrium Health Pineville (biopsy only) | Charlotte | North Carolina | 28210 | United States |
| Levine Cancer Institute-Pineville | Charlotte | North Carolina | 28210 | United States |
| Atrium Health University City (biopsy only) | Charlotte | North Carolina | 28262 | United States |
| Atrium Health Cabarrus (biopsy only) | Concord | North Carolina | 28025 | United States |
| Levine Cancer Institute Concord | Concord | North Carolina | 28025 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Atrium Health Union (biopsy only) | Monroe | North Carolina | 28112 | United States |
| OHSU Knight Cancer Institute, Beaverton | Beaverton | Oregon | 97006 | United States |
| Providence Cancer Institute Clackamas Clinic | Clackamas | Oregon | 97015 | United States |
| OHSU Knight Cancer Institute, Gresham | Gresham | Oregon | 97030 | United States |
| OHSU Knight Cancer Institute, Northwest Portland | Portland | Oregon | 97210 | United States |
| Northwest Cancer Specialists P.C. | Portland | Oregon | 97213 | United States |
| Providence Cancer Institute Franz Clinic | Portland | Oregon | 97213 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| OHSU Knight Cancer Institute, East Portland | Portland | Oregon | 97216 | United States |
| Northwest Cancer Specialists P.C. | Portland | Oregon | 97227 | United States |
| OHSU Center for Health and Healing 2 | Portland | Oregon | 97239 | United States |
| OHSU Center for Health and Healing | Portland | Oregon | 97239 | United States |
| OHSU Research Pharmacy Services | Portland | Oregon | 97239 | United States |
| Oregon Health And Science University | Portland | Oregon | 97239 | United States |
| Northwest Cancer Specialists, P.C. | Tigard | Oregon | 97223 | United States |
| OHSU Knight Cancer Institute, Tualatin | Tualatin | Oregon | 97062 | United States |
| Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| Tennessee Oncology PLLC | Dickson | Tennessee | 37055 | United States |
| Tennessee Oncology PLLC | Franklin | Tennessee | 37067 | United States |
| Tennessee Oncology PLLC | Gallatin | Tennessee | 37066 | United States |
| Tennessee Oncology PLLC | Hendersonville | Tennessee | 37075 | United States |
| Tennessee Oncology PLLC | Hermitage | Tennessee | 37076 | United States |
| Brig Center for Cancer Care and Survivorship | Knoxville | Tennessee | 37909 | United States |
| Tennessee Oncology PLLC | Lebanon | Tennessee | 37090 | United States |
| Tennessee Oncology PLLC | Murfreesboro | Tennessee | 37129 | United States |
| Tennessee Oncology PLLC | Nashville | Tennessee | 37203 | United States |
| The Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Tennessee Oncology PLLC | Nashville | Tennessee | 37205 | United States |
| Tennessee Oncology PLLC | Nashville | Tennessee | 37207 | United States |
| Tennessee Oncology PLLC | Nashville | Tennessee | 37211 | United States |
| Tennessee Oncology PLLC | Shelbyville | Tennessee | 37160 | United States |
| Tennessee Oncology PLLC | Smyrna | Tennessee | 37167 | United States |
| Texas Oncology - West Texas | Amarillo | Texas | 79124 | United States |
| The Center for Cancer and Blood Disorders | Arlington | Texas | 76014 | United States |
| Texas Oncology - Austin | Austin | Texas | 78731 | United States |
| Texas Oncology - Austin | Austin | Texas | 78745 | United States |
| Texas Oncology - DFWW | Bedford | Texas | 76022 | United States |
| Texas Oncology - DFW | Bedford | Texas | 76022 | United States |
| The Center for Cancer and Blood Disorders | Burleson | Texas | 76028 | United States |
| Texas Oncology - DFW | Dallas | Texas | 75203 | United States |
| Parkland Health and Hospital System | Dallas | Texas | 75235 | United States |
| Texas Oncology - DFWW | Dallas | Texas | 75246 | United States |
| Texas Oncology - DFW | Dallas | Texas | 75246 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| UT Southwestern Medical Center - Simmons Cancer Center Pharmacy | Dallas | Texas | 75390 | United States |
| UT Southwestern Medical Center - Simmons Cancer Center | Dallas | Texas | 75390 | United States |
| UT Southwestern University Hospital - William P. Clements, Jr | Dallas | Texas | 75390 | United States |
| UT Southwestern University Hospital - Zale Lipshy | Dallas | Texas | 75390 | United States |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| UT Southwestern Medical Center - d/b/a Moncrief Cancer Institute - Ft. Worth - Pharmacy | Fort Worth | Texas | 76104 | United States |
| UT Southwestern Medical Center d/b/a Moncrief Cancer Institute - Ft. Worth | Fort Worth | Texas | 76104 | United States |
| Oncology Consultants, P.A. | Houston | Texas | 77024 | United States |
| Texas Oncology - Gulf Coast | Houston | Texas | 77024 | United States |
| Baylor College of Medicine Medical center | Houston | Texas | 77030 | United States |
| Baylor St. Luke's Medical Center | Houston | Texas | 77030 | United States |
| Harris Health System - Ben Taub General Hospital | Houston | Texas | 77030 | United States |
| Oncology Consultants, P.A. | Houston | Texas | 77030 | United States |
| Harris Health System - Smith Clinic | Houston | Texas | 77054 | United States |
| Texas Oncology - San Antonio | New Braunfels | Texas | 78130 | United States |
| UT Southwestern Medical Center - Clinical Center Richardson/Plano - Pharmacy | Richardson | Texas | 75080 | United States |
| UT Southwestern Medical Center - Clinical Center Richardson/Plano | Richardson | Texas | 75080 | United States |
| Texas Oncology-San Antonio | San Antonio | Texas | 78217 | United States |
| Texas Oncology-San Antonio | San Antonio | Texas | 78240 | United States |
| Texas Oncology-San Antonio | San Antonio | Texas | 78258 | United States |
| The Center for Cancer and Blood Disorders | Weatherford | Texas | 76086 | United States |
| University of Utah, Farmington Health Center | Farmington | Utah | 84025 | United States |
| University of Utah, Sugar House Health Center | Salt Lake City | Utah | 84106 | United States |
| University of Utah, Huntsman Cancer Hospital | Salt Lake City | Utah | 84112 | United States |
| University of Utah, Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| University of Utah, South Jordan Health Center | South Jordan | Utah | 84009 | United States |
| Virginia Cancer Specialists, PC | Alexandria | Virginia | 22304 | United States |
| Virginia Cancer Specialists, PC | Arlington | Virginia | 22201 | United States |
| Oncology & Hematology Associates of Southwest Virginia,Inc.DBA Blue Ridge Cancer Care | Blacksburg | Virginia | 24060 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| Virginia Cancer Specialists, PC | Gainesville | Virginia | 20155 | United States |
| Virginia Cancer Specialists, PC | Leesburg | Virginia | 20176 | United States |
| Oncology and Hematology Associates of Southwest Virginia Inc | Low Moor | Virginia | 24457 | United States |
| Oncology & Hematology Associates of Southwest Virginia,Inc.DBA Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | United States |
| Oncology & Hematology Associates of Southwest Virginia,Inc.DBA Blue Ridge Cancer Care | Salem | Virginia | 24153 | United States |
| Oncology and Hematology Associates of Southwest Virginia Inc | Wytheville | Virginia | 24382 | United States |
| Swedish Cancer Institute - Issaquah Campus | Issaquah | Washington | 98029 | United States |
| Northwest Cancer Specialists P.C. | Vancouver | Washington | 98684 | United States |
| Patricia Ritchie Centre for Cancer Care and Research Mater Hospital Sydney | North Sydney | New South Wales | 2060 | Australia |
| The Crown Princess Mary Cancer Centre, Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Austin Health | Heidelberg | Victoria | 3084 | Australia |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| The Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Epic Pharmacy Hollywood | Nedlands | Western Australia | 6009 | Australia |
| Hollywood Private Hospital | Nedlands | Western Australia | 6009 | Australia |
| Starcevich Day Clinic, Hollywood Private Hospital | Nedlands | Western Australia | 6009 | Australia |
| Breast Cancer Research Centre - WA | Nedlands | 6009 | Australia |
| Universitatsklinik Innsbruck fur Gynakologie und Geburtshilfe BrustGesundheitzentrum | Innsbruck | 6020 | Austria |
| CT/MRIfacility:Diagnosezentrum Urania | Vienna | 1010 | Austria |
| Klinik Ottakring. | Vienna | 1160 | Austria |
| Wilhelminen Krebsforschung GmbH | Vienna | 1160 | Austria |
| Institut Jules Bordet | Anderlecht | Bruxelles-capitale, Région de | 1070 | Belgium |
| Clinical Trails Conduct Unit(CTCU) Institut Jules Bordet | Brussels | 1000 | Belgium |
| GHdC | Charleroi | 6000 | Belgium |
| University Hospital Antwerp | Edegem | 2650 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| CHU de Liege | Liège | 4000 | Belgium |
| CHU UCL Site Sainte Elisabeth | Namur | 5000 | Belgium |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| London Regional Cancer Program, London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| The Ottawa Hospital Cancer Centre | Ottawa | Ontario | K1H 8L6 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Centre Hospitalier de l'Universite de Motreal (CHUM) | Montreal | Quebec | H2X 3E4 | Canada |
| CHU de Québec-Université Laval, St-Sacrement Hospital | Québec | G1S 4L8 | Canada |
| Maternal and child Health Hospital of Guangdong Province | Guangzhou | Guangdong | 511442 | China |
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | China |
| Affiliated Hospital of Guangdong Medical University | Zhanjiang | Guangdong | 524000 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450003 | China |
| Hunan Cancer Hospital. | Changsha | Hu'nan | 410013 | China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | 430060 | China |
| Hubei Cancer Hospital | Wuhan | Hubei | 430079 | China |
| Nanjing Drum Tower Hospital , The Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | China |
| Xuzhou Central Hospital | Xuzhou | Jiangsu | 221009 | China |
| Nanchang Third Hospital | Nanchang | Jiangxi | China |
| Jilin Cancer Hospital | Changchun | Jilin | 130012 | China |
| Shengjing Hospital Of China Medical University | Shenyang | Liaoning | 110004 | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi’an | Shanxi | 710061 | China |
| Xi'an International Medical Center Hospital | Xi’an | Shanxi | 710100 | China |
| Zigong First People's Hospital | Zigong | Sichuan | 643000 | China |
| Tianjin Cancer Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| The First Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310002 | China |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
| Beijing Hospital | Beijing | 100010 | China |
| Cancer Hospital Chinese Academy of medical sciences | Beijing | 100021 | China |
| Peking University People's Hospital | Beijing | 100044 | China |
| Zhejiang Cancer Hospital | Hangzhou | 310022 | China |
| Guangxi Medical University Affiliated Tumor Hospital | Nanning | 530201 | China |
| Tianjin Cancer Hospital | Tianjin | China |
| Blandecentralen Odense Universitetshospital | Odense C | Other | 5000 | Denmark |
| Onkologisk Afdeling R, Odense Universitetshospital | Odense C | Other | 5000 | Denmark |
| Pharmacy. | Vejle | Other | 7100 | Denmark |
| Herlev og Gentofte Hospital | Herlev | 2730 | Denmark |
| Radiology: Herlev - og Gentofte Hospital - Radiologisk afdeling | Herlev | E2-2730 | Denmark |
| Radiology. | Vejle | 7100 | Denmark |
| Vejle Sygehus | Vejle | 7100 | Denmark |
| University Hospital of Besancon | Besançon | Other | 25030 | France |
| Service de radiologie Centre Francois Baclesse | Caen | Other | 14076 Cedex 5 | France |
| Department de Radiodiagnostic Centre GF Leclerc | Dijon | Other | 21079 Cedex | France |
| Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes | Lyon | Other | 69008 | France |
| Departement de radiologie Hopital Bretonneau - CHRU de Tours | Tours | Other | 37044 Cedex 9 | France |
| Hopital Bretonneau CHRU de Tours | Tours | Other | 37044 Cedex 9 | France |
| Pharmacie Hopital Bretonneau - CHRU de Tours | Tours | Other | 37044 Cedex 9 | France |
| Departement de radiologie Clinique Victor Hugo | Le Mans | Sarthe | 72000 | France |
| CHRU Besancon Service Radiologie | Besançon | 25000 | France |
| CHRU Besancon | Besançon | 25000 | France |
| Dimeo lmagerie Medicale Polyclinique - Besancon | Besançon | 25000 | France |
| CHRU Morvan Pharmacie des essais cliniques | Brest | 29200 | France |
| CHRU Morvan Unité de recherche clinique en cancérologie | Brest | 29200 | France |
| Centre Francois Baclesse | Caen | 14076 | France |
| Centre GF Leclerc | Dijon | 21079 | France |
| Clinique du mail | Grenoble | 38100 | France |
| Clinique Victor Hugo Centre de Cancerologie de la Sarthe | Le Mans | 72000 | France |
| Centre Leon Berard Departement de Medecine | Lyon | 69008 | France |
| Departement de radiologie Centre Leon Berard | Lyon | 69373 CEDEX 08 | France |
| Pharmacie des essais cliniques -lnstitut Paoli calmettes | Marseille | 13009 | France |
| lnstitut Paoli Calmettes, Departement ONCOLOGIE MEDICALE | Marseille | 13273 | France |
| Groupement hospitalier Portes de Provence Quartier Beausseret | Montélimar | 26216 cedex | France |
| Departement d'imagerie medicale Institut Curie - Site Paris | Paris | 75248 Cedex 05 | France |
| lnstitut Curie- Site Paris | Paris | 75248 | France |
| Centre Paul Strauss - pharmacie | Strasbourg | 67065 | France |
| lnstitut de cancerologie Strasbourg Europe | Strasbourg | 67200 | France |
| IUCT-O | Toulouse | 31059 Cedex 9 | France |
| lnstitut Claudius Regaud - IUCT-O | Toulouse | 31059 | France |
| Hopital Nord Franche-Comte Pole imagerie radiologie | Trévenans | 90400 | France |
| Universitatsmedizin Mainz | Mainz | Other | 55131 | Germany |
| Universitätsklinikum Schleswig-Holstein - Campus Kiel | Kiel | Schleswig-Holstein | 24105 | Germany |
| InVO-lnstitut für Versorgungsforschung in der Onkologie GbR | Koblenz | 56068 | Germany |
| Klinikum rechts der Isar, Klinik und Poliklinik fur Frauenheikunde | München | 81675 | Germany |
| Sana Klinikum Offenbach GmbH Zentralinstitut fur Diagnostische und Interventionelle Radiologie | Offenbach/ Main | 63069 | Germany |
| Oncology Institute, Meir Medical Center | Kfar Saba | 4428164 | Israel |
| Institute of Oncology - Davidoff Center, Rabin Medical Center, Beilinson Hospital | Petah Tikva | 4941492 | Israel |
| Oncology Institute, Kaplan Medical Center | Rehovot | 7610001 | Israel |
| A.O.U. Ospedali Riuniti di Ancona. | Torrette | Ancona | 60126 | Italy |
| Azienda Ospedaliero Universitaria di Bologna - IRCCS | Bologna | Emilia-Romagna | 40138 | Italy |
| Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi | Bologna | Emilia-Romagna | 40138 | Italy |
| Fondazione Policlinico Gemelli IRCCS | Rome | Lazio | 00168 | Italy |
| AUSL della Romagna. P.O. Ospedale degli lnfermi. U.O. di Oncologia. | Faenza | Ravenna | 48018 | Italy |
| AUSL della Romagna. P.O. Ospedale di Lugo Umberto I. U.O. di Oncologia. | Lugo | Ravenna | 48022 | Italy |
| AUSL della Romagna. P.O. Ospedale Cervesi. U.O. di Oncologia. | Cattolica | Rimini | 47841 | Italy |
| lstituto Europeo di Oncologia | Milan | 20141 | Italy |
| AUSL della Romagna. P.O. Ospedale Santa Maria delle Croci. U.O. di Oncologia. | Ravenna | 48121 | Italy |
| AUSL della Romagna P.O. Ospedale Infermi U.O. di Oncologia | Rimini | 47923 | Italy |
| Nagoya Radiological Diagnosis Foundation, East Nagoya Imaging Diagnosis Center | Nagoya | Aichi-ken | 464-0044 | Japan |
| Aichi Cancer Center Hospital | Nagoya | Aichi-ken | 464-8681 | Japan |
| National Cancer Center Hospital East. | Kashiwa | Chiba | 277-8577 | Japan |
| Hiroshima City Hiroshima Citizens Hospital | Hiroshima | Chūgoku | 730-8518 | Japan |
| National Hospital Organization Shikoku Cancer Center | Matsuyama | Ehime | 791-0280 | Japan |
| National Hospital Organization Kyushu Cancer Center. | Fukuoka | Fukuoka | 811-1395 | Japan |
| National Hospital Organization Hokkaido Cancer Center. | Sapporo | Hokkaido | 003-0804 | Japan |
| Hyogo college of medicine hospital | Nishinomiya | Hyōgo | 663-8501 | Japan |
| University of Tsukuba Hospital | Tsukuba | Ibaraki | 305-8576 | Japan |
| Hakuaikai Medical Corporation Sagara Hospital | Kagoshima | Kagoshima-ken | 892-0833 | Japan |
| Hakuaikai Medical Corporation Sagara Perth Street Clinic | Kagoshima | Kagoshima-ken | 892-0838 | Japan |
| Koyasu Neurosurgical Clinic | Yokohama | Kanagawa | 241-0821 | Japan |
| Kanagawa Cancer Center | Yokohama | Kanagawa | 241-8515 | Japan |
| Morinomiya Hospital | Osaka | Osaka | 536-0025 | Japan |
| Saitama Cancer Center, Breast Oncology | Kitaadachi-gun | Saitama | 362-0806 | Japan |
| Shizuoka Cancer Center | Nagaizumi-cho | Shizuoka | 411-8777 | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 104-0045 | Japan |
| Chiba Cancer Center | Chiba | 260-8717 | Japan |
| Advanced Imaging Center | Ibaraki | 305-8576 | Japan |
| Kumamoto Shinto General Hospital | Kumamoto | 862-8655 | Japan |
| National Hospital Organization Osaka National Hospital | Osaka | 540-0006 | Japan |
| Osaka Prefectural Hospital Organization Osaka International Cancer Institute | Osaka | 541-8567 | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | 135-8550 | Japan |
| Amphia Ziekenhuis | Breda | 4818 CK | Netherlands |
| Martini Ziekenhuis | Groningen | 9728 TN | Netherlands |
| Erasmus Medisch Centrum Daniel Den Hoed | Rotterdam | 3015 GD | Netherlands |
| National Cancer Centre Singapore | Singapore | Other | 168583 | Singapore |
| National University Hospital | Singapore | 119074 | Singapore |
| National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| National Cancer Center | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital Universitario Son Espases | Palma de Mallorca | Balearic Islands | 07120 | Spain |
| Hospital Quiron Barcelona | Barcelona | Other | 08023 | Spain |
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | Santa CRUZ DE Tenerife | 38320 | Spain |
| Vall d'Hebron University Hospital | Barcelona | 08035 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Clinica Nuestra Senora del Rosario | Madrid | 28006 | Spain |
| Hospital Ruber Internacional | Madrid | 28034 | Spain |
| Hospital Universitario Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario HM Sanchinarro | Madrid | 28050 | Spain |
| Hospital Moises Broggi- ICO | Sant Joan Despí | 08970 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Quirón Zaragoza | Zaragoza | 50006 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Sahlgrenska University Hospital | Gothenburg | 413 45 | Sweden |
| Onkologkliniken, KPE, Malpunkt K, | J0nkoping | SE-551 85 | Sweden |
| Centre Hospitalier Universitaire Vaudois | Lausanne | 1011 | Switzerland |
| Kantonsspital Winterthur Onkologie | Winterthur | 8401 | Switzerland |
| National Cheng Kung University Hospital | Tainan | 704, R.O.C. | Taiwan |
| National Taiwan University Hospital | Taipei | 100225 | Taiwan |
| The Royal Cornwall Hospital | Truro | Cornwall | TR1 3LJ | United Kingdom |
| "Edinburgh Cancer Centre, Western General Hospital," | Edinburgh | Scotland | EH4 2XU | United Kingdom |
| University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| The Royal Marsden NHS Foundation Trust | London | SW3 6JJ | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| The Royal Marsden NHS Foundation Trust | Sutton | SM2 5PT | United Kingdom |
| Placebo+ Ado-trastuzumab Emtansine |
Participants with HER2+ LA/mBC were treated with placebo orally BID, and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. |
| Intent-to-Treat (ITT) Analysis Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The ITT analysis set included all participants who were randomized on or before the date of last patient in (LPI) in the global study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tucatinib+ Ado-trastuzumab Emtansine | Participants with HER2+ LA/mBC were treated with tucatinib 300 mg orally BID and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. |
| BG001 | Placebo+ Ado-trastuzumab Emtansine | Participants with HER2+ LA/mBC were treated with placebo orally BID, and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 Based on Investigator Assessment | PFS as per investigator was defined as the time from the date of randomization to the investigator assessment of disease progression (PD) as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimiter (mm). Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. | The ITT analysis set included all participants who were randomized on or before the date of LPI, in the global study. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months) |
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| Secondary | Overall Survival (OS) | OS was defined as the time from randomization to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact). | Not Posted | Oct 2028 | Up to approximately 5 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival as Per RECIST v1.1 in Participants With Brain Metastases at Baseline Based on Investigator Assessment | PFS as per investigator was defined as the time from the date of randomization to the investigator assessment of PD as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. PFS was analyzed in participants with presence or history of brain metastases. | The ITT analysis set included all participants who were randomized on or before the date of LPI, in the global study. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 45 months) |
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| Secondary | Objective Response Rate (ORR) as Per RECIST v1.1 Based on Investigator Assessment | ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than (<)10 mm. PR: a greater than equal (>=) 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. ORR by investigator assessment is based on investigator response assessments. Two-sided 95% exact confidence interval, computed using the Clopper-Pearson method. | The ITT analysis set included all participants who were randomized on or before the date of LPI, in the global study. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of first CR or PR until the date of the first documentation of PD or death, whichever occurred first (maximum up to 43 months) |
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| Secondary | Overall Survival in Participants With Brain Metastases at Baseline | OS was defined as the time from randomization to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact). OS was analyzed in participants with presence or history of brain metastases. | Not Posted | Oct 2028 | Up to approximately 5 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival as Per RECIST v1.1 Determined by Blinded Independent Committee Review (BICR) | PFS as per BICR was defined as the time from the date of randomization to the centrally-reviewed documented PD as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without documented progression of PD or death at the time of analysis were censored at the date of the last tumor assessment. | The ITT analysis set included all participants who were randomized on or before the date of LPI, in the global study. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months) |
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| Secondary | Progression-Free Survival in Participants With Brain Metastases at Baseline as Per RECIST v1.1 Determined by BICR | PFS as per BICR was defined as the time from the date of randomization to the centrally-reviewed documented PD as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PFS was analyzed in participants with presence or history of brain metastases. | The ITT analysis set included all participants who were randomized on or before the date of LPI, in the global study. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months) |
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| Secondary | Objective Response Rate as Per RECIST v1.1 Determined by BICR | ORR was defined as the percentage of participants with confirmed CR or PR according to RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR per BICR is based on BICR response assessments. | The ITT analysis set included all participants who were randomized on or before the date of LPI, in the global study. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months) |
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| Secondary | Duration of Response (DOR) as Per RECIST v1.1 Based on Investigator Assessment | DOR was defined as the time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD as per RECIST v1.1 PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DOR per investigator was based on investigator response assessments. | Not Posted | Oct 2028 | Up to approximately 5 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response as Per RECIST v1.1 by BICR | DOR was defined as the time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD as per RECIST v1.1 PD: at least a 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DOR per BICR was based on BICR response assessments. | Not Posted | Oct 2028 | Up to approximately 5 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate (CBR) Per RECIST v1.1 Based on Investigator Assessment | CBR was defined as the percentage of participants with stable disease (SD) or non-CR or non-PD >= 6 months or best response of CR or PR according to RECIST v1.1. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CBR was based on investigator assessment. | Not Posted | Oct 2028 | Up to approximately 5 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate as Per RECIST v1.1 by BICR | CBR was defined as the percentage of participants with SD or non-CR or non-PD >= 6 months or best response of CR or PR according to RECIST v1.1. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CBR per BICR is based on BICR response assessments. | Not Posted | Oct 2028 | Up to approximately 5 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE was defined as AE that is newly occurred or worsened after the start of study treatment. | The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From start of treatment up to 30 days after the last study treatment (approximately 43 months) |
|
From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. The safety analysis set included all participants who were randomized or enrolled on or before the date of LPI in the global study and received at least 1 dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo+ Ado-trastuzumab Emtansine | Participants with HER2+ LA/mBC were treated with placebo orally BID, and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. | 63 | 233 | 52 | 233 | 227 | 233 |
| EG001 | Tucatinib+ Ado-trastuzumab Emtansine | Participants with HER2+ LA/mBC were treated with tucatinib 300 mg orally BID and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. | 71 | 231 | 70 | 231 | 230 | 231 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypertensive heart disease | Cardiac disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Otorrhoea | Ear and labyrinth disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
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| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gait inability | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Brain herniation | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Splenic injury | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hyperammonaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Systematic Assessment |
| |
| Tumour necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Central nervous system necrosis | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
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| Hydrocephalus | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Renal haemorrhage | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Diaphragmatic paralysis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v26.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Seagen Inc. | (855) 473-2436 | medinfo@seagen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 31, 2023 | Jun 24, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000705452 | tucatinib |
| D000080044 | Ado-Trastuzumab Emtansine |
| ID | Term |
|---|---|
| D008453 | Maytansine |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D000068878 | Trastuzumab |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants with HER2+ LA/mBC were treated with placebo orally BID, and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. |
|
|
|
Participants with HER2+ LA/mBC were treated with placebo orally BID, and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. |
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|