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| ID | Type | Description | Link |
|---|---|---|---|
| C4251006 | Other Identifier | Alias Study Number |
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This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan (T-DXd). It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer.
Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and T-DXd.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Tucatinib + trastuzumab deruxtecan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tucatinib | Drug | 300 mg orally twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Objective Response Rate (cORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 According to Investigator (INV) Assessment | Confirmed objective response rate was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per investigator according to RECIST v1.1. For a response to be considered confirmed, the subsequent response had to be at least 4 weeks after the initial response. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). PR: a greater than equal to (>=) 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. 95% exact confidence interval (CI) was based on Clopper-Pearson method. | From the first dose of study treatment until the first documented PD or before start of any new anti-cancer therapy (up to 43 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) Per RECIST v1.1 According to INV | PFS as per INV was defined as the time from the start of the study treatment to the first documentation of PD per RECIST v1.1 or death due to 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 (this included the baseline sum if that was 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. The appearance of one or more new lesions was also considered progression. Kaplan-Meier methods was used for analysis. |
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Inclusion Criteria
Have confirmed HER2+ breast cancer, as defined by the current American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines, previously determined at a Clinical Laboratory Improvements Amendments (CLIA)-certified or International Organization for Standardization (ISO)-accredited laboratory.
History of prior treatment with a taxane and trastuzumab in the LA/M setting OR progressed within 6 months after neoadjuvant or adjuvant treatment, including a taxane and trastuzumab.
Have progression of unresectable LA/M breast cancer after last systemic therapy (as confirmed by investigator), or be intolerant of last systemic therapy
Have measurable disease assessable by RECIST v1.1
Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
Have a life expectancy of at least 6 months, in the opinion of the investigator
CNS Inclusion - Based on medical history and screening contrast brain magnetic resonance imaging (MRI), participants with a history of brain metastases must have one of the following:
Untreated brain metastases not needing immediate local therapy. For participants with untreated central nervous system (CNS) lesions >2.0 cm on screening contrast brain MRI, discussion with and approval from the medical monitor is required prior to enrollment
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 in the opinion of the investigator
Participants treated with CNS local therapy for newly identified or previously treated progressing lesions found on contrast brain MRI performed during screening for this study may be eligible to enroll if all of the following criteria are met:
Relevant records of any CNS treatment must be available
Exclusion Criteria
Have previously been treated with:
Have received treatment with:
Have clinically significant cardiopulmonary disease (such as history of iterstitial lung disease (ILD)/pneumonitis that required systemic corticosteroids, or have current ILD/pneumonitis, or where suspected ILD /pneumonitis cannot be ruled out be imaging at screening)
Have known myocardial infarction or unstable angina within 6 months prior to first dose of study treatment
Known to be positive for hepatitis B by surface antigen expression. Known to be positive for hepatitis C infection. Participants who have been treated for hepatitis C infection are permitted if they have documented sustained virologic response of 12 weeks
Presence of known chronic liver disease
Active or uncontrolled clinically serious infection
Have inability to swallow pills or significant gastrointestinal disease which would preclude the adequate oral absorption of medications
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| University of Alabama at Birmingham, IDS Pharmacy |
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| 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 94 participants were screened of which 24 failed screening, and 70 participants were enrolled in the study. Participants who continued to receive clinical benefit after end of study could continue to receive study treatment during the long-term extension phase (LTEP).
Participants diagnosed with unresectable locally advanced or metastatic (LA/M) human epidermal growth factor receptor 2 positive (HER2+) breast cancer (BC) with or without brain metastases, who received prior treatment with a taxane and trastuzumab or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including a taxane and trastuzumab (with or without pertuzumab) were enrolled at 24 sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Total Participants | Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300 milligram (mg) orally (PO) twice daily (BID) on Days 1 to 21 and Trastuzumab Deruxtecan (T-DXd) 5.4 milligram per kilogram (mg/kg) intravenous (IV) on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, progressive disease (PD), investigator or participants decision to discontinue, or study closure. |
| 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 | Oct 16, 2024 | Jul 8, 2025 |
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| trastuzumab deruxtecan | Drug | 5.4 mg/kg via intravenous (into the vein; IV) infusion on Day 1 of each of 21-day cycle |
|
|
| From the start of study treatment until the first documentation of PD or death due to any cause, whichever occurred first (approximately 46.2 months of treatment exposure) |
| Duration of Response (DOR) Per RECIST v1.1 According to INV | DOR was defined as the time from the date of first documented objective response (CR or PR that was subsequently confirmed) to the date of first documented PD per RECIST v1.1 or death due to 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 (this included the baseline sum if that was 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. The appearance of one or more new lesions was also considered progression. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) 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 of diameters. Kaplan-Meier methods was used for analysis. | From the first documented objective response until the first documentation of PD or death, whichever occurred first (approximately 46.2 months) |
| Disease Control Rate (DCR) Per RECIST v1.1 | DCR was defined as percentage of participants with confirmed CR, PR or stable disease ([SD] or non-CR/non-PD) per RECIST v1.1. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) 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 of diameters. 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 included the baseline sum if that was 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. The appearance of one or more new lesions was also considered progression. 95% CI was computed using Clopper-Pearson method. | From first dose of study treatment until PD or death, whichever occurred first (approximately 46.2 months) |
| Overall Survival (OS) | OS was defined as the time from the start of study treatment to the date of death due to any cause. Participants who were not known to have died at 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). For participants without data beyond the day of treatment initiation, OS was censored on the date of treatment initiation. Kaplan-Meier methods was used for analysis. | From date of start of study treatment until date of death or censoring date (approximately 46.2 months) |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigational participant administered a medicinal product which did not necessarily have a causal relationship with this treatment. AEs included all non-serious adverse events (non-SAEs) and SAEs. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib or trastuzumab deruxtecan) and up through 30 days after the last dose of study treatment. | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months) |
| Number of Participants With Serious Adverse Events (SAEs) | An SAE was an AE that at any dose, met any of the following criteria: resulted in death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or disability (substantial disruption of the participant's ability to conduct normal life functions), congenital anomaly/birth defect or considered medically significant. | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months) |
| Number of Participants With Treatment Emergent Adverse Events Based on Severity | An AE was defined was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib or trastuzumab deruxtecan) and up through 30 days after the last dose of study treatment. AEs were graded based on National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0 where, grade 1= mild; grade 2= moderate; grade 3= severe; grade 4= life-threatening; grade 5= death. | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months) |
| Number of Participants With Treatment Related TEAEs | An AE was defined was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib or trastuzumab deruxtecan) and up through 30 days after the last dose of study treatment. Relatedness of AEs to study treatment was determined by the investigator. | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months) |
| Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities | Laboratory abnormalities included: hematology; hemoglobin increased and decreased, leukocytes decreased, lymphocytes increased and decreased, neutrophils decreased and platelets decreased. Chemistry: alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatinine, magnesium, potassium, sodium and total bilirubin increased and glucose, magnesium, potassium and sodium decreased. Treatment-emergent laboratory abnormalities were defined as abnormalities that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. Laboratory test results were graded according to NCI CTCAE version 4.03, where Grade 0: no AE, Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Number of participants with any grade are reported in this outcome measure. | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months) |
| Number of Participants With TEAEs Leading to Dose Modification | An AE was defined was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib or trastuzumab deruxtecan) and up through 30 days after the last dose of study treatment. Dose modification included dose reduction, dose delay, dose hold and dose interruption. Number of participants with TEAEs leading to any type of dose modification for tucatinib and T-DXd are reported in this outcome measure. | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months) |
| Number of Participants With TEAEs Leading to Treatment Discontinuation | An AE was defined was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib or trastuzumab deruxtecan) and up through 30 days after the last dose of study treatment. In this outcome measure, participants with TEAEs leading to discontinuation of tucatinib and T-DXd treatment is reported. | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months) |
| Number of Participants According to Change From Baseline Categories in Ejection Fraction | Cardiac ejection fraction was assessed using multiple-gated acquisition scan (MUGA) or echocardiogram (ECHO). Baseline was defined as most recent non-missing assessment on or before first dose date. Number of participants according to change from baseline in ejection fraction categories (i.e., no decrease, decrease <10%, decrease 10-<20% and decrease >=20%) is reported in this outcome measure. | Baseline up to 30 days after last dose of study treatment (approximately 47.2 months) |
| Number of Participants With Clinically Significant Vital Signs | Vital signs included body temperature, respiratory rate, heart rate, oxygen saturation, and systolic blood pressure (SBP) and diastolic blood pressure (DBP). The clinically significant vital signs were defined as: heart rate > 100 beats per minute (bpm), temperature >=38.0 degrees Celsius (C), respiratory rate > 20 breaths per minute and oxygen saturation < 88%; SBP >=120 millimeters of mercury (mmHg) or DBP >=80 mmHg; SBP >=140 mmHg or DBP >=90 mmHg and SBP >=160 mmHg or DBP>=100 mmHg. | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months) |
| Birmingham |
| Alabama |
| 35249 |
| United States |
| University Of Alabama at Birmingham | Birmingham | Alabama | 35249 | 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 |
| UCLA Hematology/Oncology - Burbank | Burbank | California | 91505 | United States |
| City of Hope (City of Hope National Medical Center, City of Hope Medical center) | Duarte | California | 91010 | United States |
| City of Hope Investigational Drug Services (IDS) | Duarte | California | 91010 | United States |
| UCLA Hematology/Oncology - Laguna Hills | Laguna Hills | California | 92653 | United States |
| (IRB# 20-001502) Ronald Reagan UCLA Medical Center, Drug Information Center | Los Angeles | California | 90095 | United States |
| UCLA Hematology/Oncology | Los Angeles | California | 90095 | United States |
| UCLA Hematology/Oncology - Pasadena | Pasadena | California | 91105 | United States |
| Zuckerberg San Francisco General Hospital- Breast Clinic | San Francisco | California | 94110 | United States |
| Zuckerberg San Francisco General Hospital- Oncology Clinic | San Francisco | California | 94110 | United States |
| University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94158 | United States |
| UCLA Hematology/Oncology - San Luis Obispo | San Luis Obispo | California | 93401 | United States |
| UCLA Hematology/Oncology - Santa Barbara | Santa Barbara | California | 93105 | United States |
| UCLA Hematology/Oncology - Santa Monica | Santa Monica | California | 90404 | United States |
| UCLA Hematology/Oncology Parkside | Santa Monica | California | 90404 | United States |
| UCLA Hematology/Oncology - Ventura | Ventura | California | 93003 | United States |
| UCLA Hematology/Oncology - Westlake | Westlake Village | California | 91361 | United States |
| University of Colorado Denver CTO/CTRC - Outpatient. | 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 |
| UC Health Lone Tree Medical Center | Lone Tree | Colorado | 80124 | 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 | Brandon | Florida | 33511 | United States |
| Florida Cancer Specialists | Clearwater | Florida | 33761 | United States |
| Florida Cancer Specialists | Gainesville | Florida | 32605 | United States |
| Florida Cancer Specialists | Largo | Florida | 33770 | United States |
| Florida Cancer Specialists | Lecanto | Florida | 34461 | United States |
| Florida Cancer Specialists | Ocala | Florida | 34474 | United States |
| Florida Cancer Specialists | Orange City | Florida | 32763 | United States |
| Florida Cancer Specialists | Orlando | Florida | 32806 | United States |
| Florida Cancer Specialists | St. Petersburg | Florida | 33705 | United States |
| Florida Cancer Specialists | Tampa | Florida | 33607 | 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 | Winter Park | Florida | 32789 | United States |
| Northside Hospital, Inc - GCS/Athens | Athens | Georgia | 30606 | United States |
| Winship Cancer Institute @ Emory University Hospital Midtown | Atlanta | Georgia | 30308 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| The Emory Clinic | Atlanta | Georgia | 30322 | United States |
| Winship Cancer Institute / Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| Winship Cancer Institute | 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/Center Pointe | Atlanta | Georgia | 30342 | United States |
| Northside Hospital, Inc - GCS/Blairsville | Blairsville | Georgia | 30512 | United States |
| Northside Hospital, Inc - GCS/Canton | Canton | Georgia | 30114 | United States |
| Atlanta Cancer Care - Cumming | Cumming | Georgia | 30041 | United States |
| Northside Hospital, Inc. - GCS/Decatur | Decatur | Georgia | 30033 | United States |
| NHCI Suburban Hematology-oncology Associates - Duluth | Duluth | Georgia | 30096 | United States |
| NHCI Suburban Hematology-oncology Associates - lawrenceville | Lawrenceville | Georgia | 30046 | United States |
| Northside Hospital, Inc - GCS/Macon | Macon | Georgia | 31217 | United States |
| Northside Hospital, Inc. - GCS/Marietta | Marietta | Georgia | 30060 | United States |
| Atlanta Cancer Care - Stockbridge | Stockbridge | Georgia | 30281 | United States |
| Harry and Jeanette Weinberg Cancer Institute at Franklin Square | Baltimore | Maryland | 21237 | United States |
| Brigham and 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 |
| Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Minnesota Oncology Hematology, PA | Coon Rapids | Minnesota | 55433 | United States |
| Mercy Hospital - Unity Campus | Fridley | Minnesota | 55432 | United States |
| Minnesota Oncology Hematology, PA | Fridley | Minnesota | 55433 | United States |
| Minnesota Oncology Hematology, PA | Minneapolis | Minnesota | 55404 | United States |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Allina Health Cancer institute | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Allina Health Cancer Institute | Saint Paul | Minnesota | 55102 | United States |
| Minnesota Oncology Hematology PA | Saint Paul | Minnesota | 55102 | United States |
| Minnesota Oncology Hematology, PA | Saint Paul | Minnesota | 55102 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | 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 |
| Oncology Hematology West, PC dba Nebraska Cancer Specialists | Papillion | Nebraska | 68046 | United States |
| MSK Basking Ridge | Basking Ridge | New Jersey | 07920 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| MSK Monmouth | Middletown | New Jersey | 07748 | United States |
| MSK Bergen | Montvale | New Jersey | 07645 | United States |
| MSK Commack | Commack | New York | 11725 | United States |
| MSK Westchester | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy | Long Island City | New York | 11101 | United States |
| Evelyn H. Lauder Breast and Imaging Center (BAIC). | New York | New York | 10065 | United States |
| MSK Nassau | Uniondale | New York | 11553 | United States |
| Providence Cancer Institute Franz Clinic | Portland | Oregon | 97213 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| UPMC Hillman Cancer Center Passavant North | Cranberry Township | Pennsylvania | 16066 | United States |
| UPMC Hillman Cancer Center Erie | Erie | Pennsylvania | 16505 | United States |
| UPMC Hillman Cancer Center Mountainview | Greensburg | Pennsylvania | 15601 | United States |
| UPMC Hillman Cancer Center UPMC East | Monroeville | Pennsylvania | 15146 | United States |
| UPMC Hillman Cancer Center Upper Saint Clair | Pittsburgh | Pennsylvania | 15102 | United States |
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Pittsburgh Cancer Institute Investigational Drug Service UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| UPMC Cancer Centers William M. Cooper Ambulatory Care Pavilion of the Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| UPMC Hillman Cancer Center UPMC Passavant | Pittsburgh | Pennsylvania | 15237 | United States |
| UPMC Hillman Cancer Center Uniontown | Uniontown | Pennsylvania | 15401 | United States |
| UPMC Hillman Cancer Center Washington | Washington | Pennsylvania | 15301 | United States |
| Tennessee Oncology, PLLC | Chattanooga | Tennessee | 37403 | United States |
| Sarah Cannon Research Institute | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Oncology, PLLC | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Oncology, PLLC | Cleveland | Tennessee | 37311 | 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 |
| Tennessee Oncology, PLLC | Lebanon | Tennessee | 37909 | 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 |
| The University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| U.T. MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| US Oncology Investigational Product Center (IPC) | Irving | Texas | 75063 | United States |
| US Oncology Investigational Products Center (IPC) | Irving | Texas | 75063 | United States |
| US Oncology lnvestigational Products Center (IPC) | Irving | Texas | 75063 | United States |
| Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A 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 & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care | Low Moor | Virginia | 24457 | United States |
| Virginia Cancer Specialists, PC | Reston | Virginia | 20190 | United States |
| Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | United States |
| Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care | Salem | Virginia | 24153 | United States |
| Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care | Wytheville | Virginia | 24382 | United States |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| UW Health Oncology - One South Park | Madison | Wisconsin | 53715 | United States |
| University of Wisconsin Clinical Science Center | Madison | Wisconsin | 53792 | United States |
| COMPLETED |
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| NOT COMPLETED |
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The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Participants | Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300mg PO BID on Days 1 to 21 and T-DXd 5.4 mg/kg IV on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, PD, investigator or participants decision to discontinue, or study closure. |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Presence or history of treated or untreated brain metastases | Count of Participants | Participants |
| |||||||||||||||||||||||
| HER2 testing results | Count of Participants | Participants |
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| 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 | Confirmed Objective Response Rate (cORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 According to Investigator (INV) Assessment | Confirmed objective response rate was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per investigator according to RECIST v1.1. For a response to be considered confirmed, the subsequent response had to be at least 4 weeks after the initial response. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). PR: a greater than equal to (>=) 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. 95% exact confidence interval (CI) was based on Clopper-Pearson method. | Response-evaluable analysis set included all participants with measurable disease who (1) had a baseline disease assessment, (2) received at least one dose of study drug (tucatinib and/or trastuzumab deruxtecan), and (3) had at least 1 post-baseline assessment or discontinued treatment due to PD, clinical progression, toxicity, or death. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the first dose of study treatment until the first documented PD or before start of any new anti-cancer therapy (up to 43 months) |
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| Secondary | Progression-Free Survival (PFS) Per RECIST v1.1 According to INV | PFS as per INV was defined as the time from the start of the study treatment to the first documentation of PD per RECIST v1.1 or death due to 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 (this included the baseline sum if that was 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. The appearance of one or more new lesions was also considered progression. Kaplan-Meier methods was used for analysis. | The all treated participants includes all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan). | Posted | Median | 95% Confidence Interval | Months | From the start of study treatment until the first documentation of PD or death due to any cause, whichever occurred first (approximately 46.2 months of treatment exposure) |
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| Secondary | Duration of Response (DOR) Per RECIST v1.1 According to INV | DOR was defined as the time from the date of first documented objective response (CR or PR that was subsequently confirmed) to the date of first documented PD per RECIST v1.1 or death due to 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 (this included the baseline sum if that was 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. The appearance of one or more new lesions was also considered progression. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) 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 of diameters. Kaplan-Meier methods was used for analysis. | The response-evaluable analysis set included all participants with measurable disease who (1) had a baseline disease assessment, (2) received at least one dose of study drug (tucatinib and/or trastuzumab deruxtecan), and (3) had at least 1 post-baseline assessment or discontinued treatment due to PD, clinical progression, toxicity, or death. | Posted | Median | 95% Confidence Interval | Months | From the first documented objective response until the first documentation of PD or death, whichever occurred first (approximately 46.2 months) |
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| Secondary | Disease Control Rate (DCR) Per RECIST v1.1 | DCR was defined as percentage of participants with confirmed CR, PR or stable disease ([SD] or non-CR/non-PD) per RECIST v1.1. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) 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 of diameters. 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 included the baseline sum if that was 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. The appearance of one or more new lesions was also considered progression. 95% CI was computed using Clopper-Pearson method. | The response-evaluable analysis set included all participants with measurable disease who (1) had a baseline disease assessment, (2) received at least one dose of study drug (tucatinib and/or trastuzumab deruxtecan), and (3) had at least 1 post-baseline assessment or discontinued treatment due to PD, clinical progression, toxicity, or death. | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose of study treatment until PD or death, whichever occurred first (approximately 46.2 months) |
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| Secondary | Overall Survival (OS) | OS was defined as the time from the start of study treatment to the date of death due to any cause. Participants who were not known to have died at 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). For participants without data beyond the day of treatment initiation, OS was censored on the date of treatment initiation. Kaplan-Meier methods was used for analysis. | The all-treated participants included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan). | Posted | Median | 95% Confidence Interval | Months | From date of start of study treatment until date of death or censoring date (approximately 46.2 months) |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigational participant administered a medicinal product which did not necessarily have a causal relationship with this treatment. AEs included all non-serious adverse events (non-SAEs) and SAEs. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib or trastuzumab deruxtecan) and up through 30 days after the last dose of study treatment. | The all-treated participants included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan). | Posted | Count of Participants | Participants | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months) |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) | An SAE was an AE that at any dose, met any of the following criteria: resulted in death, was life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or disability (substantial disruption of the participant's ability to conduct normal life functions), congenital anomaly/birth defect or considered medically significant. | The all-treated participants included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan). | Posted | Count of Participants | Participants | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months) |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events Based on Severity | An AE was defined was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib or trastuzumab deruxtecan) and up through 30 days after the last dose of study treatment. AEs were graded based on National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0 where, grade 1= mild; grade 2= moderate; grade 3= severe; grade 4= life-threatening; grade 5= death. | The all-treated participants included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan). | Posted | Count of Participants | Participants | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months) |
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| Secondary | Number of Participants With Treatment Related TEAEs | An AE was defined was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib or trastuzumab deruxtecan) and up through 30 days after the last dose of study treatment. Relatedness of AEs to study treatment was determined by the investigator. | The all-treated participants included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan). | Posted | Count of Participants | Participants | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months) |
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| Secondary | Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities | Laboratory abnormalities included: hematology; hemoglobin increased and decreased, leukocytes decreased, lymphocytes increased and decreased, neutrophils decreased and platelets decreased. Chemistry: alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatinine, magnesium, potassium, sodium and total bilirubin increased and glucose, magnesium, potassium and sodium decreased. Treatment-emergent laboratory abnormalities were defined as abnormalities that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. Laboratory test results were graded according to NCI CTCAE version 4.03, where Grade 0: no AE, Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Number of participants with any grade are reported in this outcome measure. | The all-treated participants included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan). | Posted | Count of Participants | Participants | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months) |
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| Secondary | Number of Participants With TEAEs Leading to Dose Modification | An AE was defined was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib or trastuzumab deruxtecan) and up through 30 days after the last dose of study treatment. Dose modification included dose reduction, dose delay, dose hold and dose interruption. Number of participants with TEAEs leading to any type of dose modification for tucatinib and T-DXd are reported in this outcome measure. | The all-treated participants included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan). | Posted | Count of Participants | Participants | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months) |
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| Secondary | Number of Participants With TEAEs Leading to Treatment Discontinuation | An AE was defined was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as a newly occurring or worsening AE after the first dose of study treatment (tucatinib or trastuzumab deruxtecan) and up through 30 days after the last dose of study treatment. In this outcome measure, participants with TEAEs leading to discontinuation of tucatinib and T-DXd treatment is reported. | The all-treated participants included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan). | Posted | Count of Participants | Participants | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months) |
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| Secondary | Number of Participants According to Change From Baseline Categories in Ejection Fraction | Cardiac ejection fraction was assessed using multiple-gated acquisition scan (MUGA) or echocardiogram (ECHO). Baseline was defined as most recent non-missing assessment on or before first dose date. Number of participants according to change from baseline in ejection fraction categories (i.e., no decrease, decrease <10%, decrease 10-<20% and decrease >=20%) is reported in this outcome measure. | The all-treated participants included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan). Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline up to 30 days after last dose of study treatment (approximately 47.2 months) |
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| Secondary | Number of Participants With Clinically Significant Vital Signs | Vital signs included body temperature, respiratory rate, heart rate, oxygen saturation, and systolic blood pressure (SBP) and diastolic blood pressure (DBP). The clinically significant vital signs were defined as: heart rate > 100 beats per minute (bpm), temperature >=38.0 degrees Celsius (C), respiratory rate > 20 breaths per minute and oxygen saturation < 88%; SBP >=120 millimeters of mercury (mmHg) or DBP >=80 mmHg; SBP >=140 mmHg or DBP >=90 mmHg and SBP >=160 mmHg or DBP>=100 mmHg. | The all-treated participants included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan). | Posted | Count of Participants | Participants | From first dose of the study treatment (Day 1) up to 30 days after the last dose of study treatment (approximately 47.2 months) |
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From start of study treatment (Day 1) up to 30 days after last dose of study treatment (approximately 47.2 months)
Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. The all-treated participants analysis set included all participants who received any amount of study drug (tucatinib and/or trastuzumab deruxtecan).
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 | Total Participants | Participants with HER2+ LA/mBC with or without history of brain metastases received tucatinib 300mg PO BID on Days 1 to 21 and T-DXd 5.4 mg/kg IV on Day 1 of each 21-day cycle. Participants received treatment until unacceptable toxicity, PD, investigator or participants decision to discontinue, or study closure. | 39 | 70 | 25 | 70 | 70 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v28.0 | Systematic Assessment |
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| Ventricular fibrillation | Cardiac disorders | MedDRA v28.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Enterocolitis | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA v28.0 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
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| Brain oedema | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
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| Trigeminal neuralgia | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA v28.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA v28.0 | Systematic Assessment |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA v28.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA v28.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v28.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA v28.0 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA v28.0 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA v28.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA v28.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA v28.0 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA v28.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA v28.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA v28.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA v28.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA v28.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v28.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA v28.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA v28.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA v28.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA v28.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA v28.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA v28.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v28.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA v28.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA v28.0 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA v28.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Systematic Assessment |
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| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA v28.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA v28.0 | Systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 8007181021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 20, 2024 | Jul 8, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000705452 | tucatinib |
| C000614160 | trastuzumab deruxtecan |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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