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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7119-001 | Other Identifier | Merck | |
| jRCT2051200152 | Registry Identifier | jRCT |
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The goal of this study is to evaluate the efficacy and safety of tucatinib in combination with trastuzumab and capecitabine in participants with unresectable locally advanced or metastatic HER2+ breast cancer who have had prior treatment with taxane anti-cancer agent, trastuzumab, pertuzumab and trastuzumab emtansine (T-DM1). The primary hypothesis is that the confirmed objective response rate (cORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by independent central review (ICR) for the combination of tucatinib, trastuzumab and capecitabine, is greater than 20%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tucatinib + Trastuzumab + Capecitabine | Experimental | Participants will receive tucatinib plus trastuzumab plus capecitabine. Tucatinib 300 mg will be administered orally twice daily (BID). Trastuzumab 8 mg/kg loading dose followed by 6 mg/kg maintenance dose thereafter, will be administered intravenously (IV) on Day 1 of each 21-day cycle. Capecitabine 1000 mg/m^2 will be administered orally BID on Days 1-14 of each 21-day cycle. Tucatinib, trastuzumab and capecitabine treatment will continue until unacceptable toxicity, disease progression, death, withdrawal of consent or study closure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tucatinib | Drug | Tucatinib 300 mg administered BID via oral tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Objective Response Rate(cORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Determined by Independent Central Review (ICR): Japanese Participants | cORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR), per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 millimeter(mm). PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented progressive disease(PD) or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study(included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Participants with missing data were considered non-responders. cORR was determined by ICR. Two-sided 90% exact confidence interval was based on Clopper-Pearson method. | From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first (maximum up to 17.8 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Objective Response Rate(cORR) Per RECIST Version 1.1 Determined by ICR: All Participants | cORR was defined as percentage of participants with confirmed CR or PR, per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Participants with missing data were considered non-responders. cORR was determined by ICR. Two-sided 90% exact confidence interval was based on Clopper-Pearson method. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Cancer Center Hospital ( Site 1013) | Nagoya | Aichi-ken | 464-8681 | Japan | ||
| Nagoya University Hospital ( Site 1021) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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A total of 66 participants were enrolled in this study across Japan, Taiwan and South Korea. Results reported are based on the primary completion date of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tucatinib + Capecitabine + Trastuzumab | Participants with locally advanced unresectable or metastatic HER2+ breast cancer who have had prior treatment with taxane anti-cancer agent, trastuzumab, pertuzumab, and trastuzumab emtansine (T-DM1) were administered Tucatinib 300 mg tablets orally BID, Capecitabine tablets 1000 mg/m^2 orally BID on Days 1 to 14 of each 21-day cycle and Trastuzumab was administered as a loading dose of 8 mg/kg IV followed by 6 mg/kg once every 21 days until unacceptable toxicity, disease progression, death, withdrawal of consent, 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 | Feb 28, 2024 | Jul 15, 2024 |
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| Trastuzumab | Biological | Trastuzumab 8 mg/kg loading dose followed by 6 mg/kg maintenance dose, administered via IV infusion |
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| Capecitabine | Drug | Capecitabine 1000 mg/m^2 administered BID via oral tablet |
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| From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first |
| Confirmed Objective Response Rate(cORR) Per RECIST Version 1.1 Determined by Investigator Assessment (INV): Japanese Participants | cORR was defined as percentage of participants with confirmed CR or PR, per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Participants with missing data were considered non-responders. cORR was determined by INV. Two-sided 90% exact confidence interval was based on Clopper-Pearson method. | From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first |
| Confirmed Objective Response Rate(cORR) Per RECIST Version 1.1 Determined by INV: All Participants | cORR was defined as percentage of participants with confirmed CR or PR, per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Participants with missing data were considered non-responders. cORR was determined by ICR. Two-sided 90% exact confidence interval was based on Clopper-Pearson method. | From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first |
| Duration of Response (DOR) Per RECIST Version 1.1 Determined by INV: All Participants | DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to documented PD per RECIST version 1.1 or death from any cause, whichever occurred first. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Only those participants who achieved a confirmed response will be included in the analysis. DOR was determined by INV. | From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first |
| Duration of Response (DOR) Per RECIST Version 1.1 Determined by INV: Japanese Participants | DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to documented PD per RECIST version 1.1 or death from any cause, whichever occurred first. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Only those participants who achieved a confirmed response will be included in the analysis. DOR was determined by INV. | From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first |
| Duration of Response (DOR) Per RECIST Version 1.1 Determined by ICR: All Participants | DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to documented PD per RECIST version 1.1 or death from any cause, whichever occurred first. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Only those participants who achieved a confirmed response will be included in the analysis. DOR was determined by ICR. | From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first |
| Duration of Response (DOR) Per RECIST Version 1.1 Determined by ICR: Japanese Participants | DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to documented PD per RECIST version 1.1 or death from any cause, whichever occurred first. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Only those participants who achieved a confirmed response will be included in the analysis. DOR was determined by ICR. | From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first |
| Progression Free Survival (PFS) Per RECIST Version 1.1 Determined by ICR: All Participants | PFS time was defined as the time from the first date of study treatment to the date of documented disease progression using RECIST v1.1 or death from any cause, whichever occurred first. Participants who were alive and had not progressed at the time of the analysis were censored at the time of their last tumor assessment documenting absence of PD. Participants lacking an evaluation of tumor response after their start of study treatment had their event time censored at 1 day. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. PFS was determined by ICR. | From date of first dose to the date of documented disease progression or death from any cause whichever occurred first or censoring date |
| Progression Free Survival (PFS) Per RECIST Version 1.1 Determined by ICR: Japanese Participants | PFS time was defined as the time from the first date of study treatment to the date of documented disease progression using RECIST v1.1 or death from any cause, whichever occurred first. Participants who were alive and had not progressed at the time of the analysis were censored at the time of their last tumor assessment documenting absence of PD. Participants lacking an evaluation of tumor response after their start of study treatment had their event time censored at 1 day. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. PFS was determined by ICR. | From date of first dose to the date of documented disease progression or death from any cause whichever occurred first or censoring date |
| Progression Free Survival (PFS) Per RECIST Version 1.1 Determined by INV: All Participants | PFS time was defined as the time from the first date of study treatment to the date of documented disease progression using RECIST v1.1 or death from any cause, whichever occurred first. Participants who were alive and had not progressed at the time of the analysis were censored at the time of their last tumor assessment documenting absence of PD. Participants lacking an evaluation of tumor response after their start of study treatment had their event time censored at 1 day. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. PFS was determined by INV. | From date of first dose to the date of documented disease progression or death from any cause whichever occurred first or censoring date |
| Progression Free Survival (PFS) Per RECIST Version 1.1 Determined by INV: Japanese Participants | PFS time was defined as the time from the first date of study treatment to the date of documented disease progression using RECIST v1.1 or death from any cause, whichever occurred first. Participants who were alive and had not progressed at the time of the analysis were censored at the time of their last tumor assessment documenting absence of PD. Participants lacking an evaluation of tumor response after their start of study treatment had their event time censored at 1 day. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. PFS was determined by INV. | From date of first dose to the date of documented disease progression or death from any cause whichever occurred first or censoring date |
| Overall Survival: All Participants | OS was defined as the time from start of study treatment to date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. Participants lacking data beyond their start of study treatment had their survival time censored at 1 day. | From start of study treatment to date of death from any cause or censoring date |
| Overall Survival: Japanese Participants | OS was defined as the time from start of study treatment to date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. Participants lacking data beyond their start of study treatment had their survival time censored at 1 day. | From start of study treatment to date of death from any cause or censoring date |
| Number of Participants With Adverse Events, Serious Adverse Events and Treatment Related Adverse Events and Serious Adverse Events: All Participants | An adverse event was defined as any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Serious adverse event was any untoward medical occurrence at any dose that resulted in death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect or that was considered as an important medical event. Treatment related adverse events and serious adverse events was judged by investigator. | From date of first dose of study treatment to up to 30 days after last dose of study treatment |
| Number of Participants With Adverse Events, Serious Adverse Events and Treatment Related Adverse Events and Serious Adverse Events: Japanese Participants | An adverse event was defined as any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. t intervention indicated and Grade 5 indicates death related to AE. Participants who discontinued treatment due to AEs were captured under AEs leading to treatment discontinuation. SAE was any untoward medical occurrence at any dose that resulted in death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect or that was considered as an important medical event. Treatment related adverse events and serious adverse events was judged by investigator. | From date of first dose of study treatment to up to 30 days after last dose of study treatment |
| Number of Participants With Abnormalities in Laboratory Parameters: All Participants | From date of first dose of study treatment to up to 30 days after last dose of study treatment |
| Number of Participants With Abnormalities in Laboratory Parameters: Japanese Participants | From date of first dose of study treatment to up to 30 days after last dose of study treatment |
| Number of Participants With Dose Modifications and Treatment Discontinuations: All Participants | From date of first dose of study treatment to up to 30 days after last dose of study treatment |
| Number of Participants With Dose Modifications and Treatment Discontinuations: Japanese Participants | From date of first dose of study treatment to up to 30 days after last dose of study treatment |
| Number of Participants With Clinically Significant Changes in Vital Signs: All Participants | From date of first dose of study treatment to up to 30 days after last dose of study treatment |
| Number of Participants With Clinically Significant Changes in Vital Signs: Japanese Participants | From date of first dose of study treatment to up to 30 days after last dose of study treatment |
| Nagoya |
| Aichi-ken |
| 466-8560 |
| Japan |
| National Cancer Center Hospital East ( Site 1002) | Kashiwa | Chiba | 2778577 | Japan |
| National Hospital Organization Shikoku Cancer Center ( Site 1014) | Matsuyama | Ehime | 791-0280 | Japan |
| National Hospital Organization Hokkaido Cancer Center ( Site 1017) | Sapporo | Hokkaido | 003-0804 | Japan |
| Hokkaido University Hospital ( Site 1022) | Sapporo | Hokkaido | 060-8648 | Japan |
| Hyogo Cancer Center ( Site 1005) | Akashi | Hyōgo | 673-8558 | Japan |
| Hyogo College of Medicine Hospital ( Site 1019) | Nishinomiya | Hyōgo | 663-8501 | Japan |
| University of Tsukuba Hospital ( Site 1020) | Tsukuba | Ibaraki | 305-8576 | Japan |
| Kanagawa Cancer Center ( Site 1010) | Yokohama | Kanagawa | 241-8515 | Japan |
| Medical Corporation Nahanishikai Nahanishi Clinic ( Site 1016) | Naha | Okinawa | 901-0154 | Japan |
| Saitama Cancer Center ( Site 1018) | Kitaadachi-gun | Saitama | 362-0806 | Japan |
| National Hospital Organization Kyushu Cancer Center ( Site 1009) | Fukuoka | 811-1395 | Japan |
| Fukushima Medical University Hospital ( Site 1012) | Fukushima | 960-1295 | Japan |
| Hiroshima City Hiroshima Citizens Hospital ( Site 1024) | Hiroshima | 730-8518 | Japan |
| Social medical corporation Hakuaikai Sagara Hospital ( Site 1008) | Kagoshima | 892-0833 | Japan |
| Kumamoto Shinto General Hospital ( Site 1007) | Kumamoto | 862-8655 | Japan |
| National Hospital Organization Osaka National Hospital ( Site 1001) | Osaka | 540-0006 | Japan |
| Osaka International Cancer Institute ( Site 1004) | Osaka | 541-8567 | Japan |
| National Cancer Center Hospital ( Site 1003) | Tokyo | 104-0045 | Japan |
| Juntendo University Hospital ( Site 1025) | Tokyo | 113-0033 | Japan |
| The Cancer Institute Hospital of JFCR ( Site 1015) | Tokyo | 135-8550 | Japan |
| Showa University Hospital ( Site 1023) | Tokyo | 142-8666 | Japan |
| Tokyo Medical University Hospital ( Site 1006) | Tokyo | 160-0023 | Japan |
| Seoul National University Hospital ( Site 2003) | Seoul | 03080 | South Korea |
| Severance Hospital ( Site 2001) | Seoul | 03722 | South Korea |
| Samsung Medical Center ( Site 2002) | Seoul | 06351 | South Korea |
| National Cheng Kung University Hospital ( Site 3000) | Dawan | Tainan | 704 | Taiwan |
| Japanese Participants |
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| COMPLETED |
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| NOT COMPLETED |
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All treated participants set included all participants who received any amount of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tucatinib + Capecitabine + Trastuzumab | Participants with locally advanced unresectable or metastatic HER2+ breast cancer who have had prior treatment with taxane anti-cancer agent, trastuzumab, pertuzumab, and trastuzumab emtansine (T-DM1) were administered Tucatinib 300 mg tablets orally BID, Capecitabine tablets 1000 mg/m^2 orally BID on Days 1 to 14 of each 21-day cycle and Trastuzumab was administered as a loading dose of 8 mg/kg IV followed by 6 mg/kg once every 21 days until unacceptable toxicity, disease progression, death, withdrawal of consent, or study closure. |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 | ||||||||||||||||||||
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| Primary | Confirmed Objective Response Rate(cORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Determined by Independent Central Review (ICR): Japanese Participants | cORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR), per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 millimeter(mm). PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented progressive disease(PD) or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study(included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Participants with missing data were considered non-responders. cORR was determined by ICR. Two-sided 90% exact confidence interval was based on Clopper-Pearson method. | Response evaluable set for Japanese population included all Japanese participants enrolled in Japanese sites who met all of the following criteria: (1) had measurable disease at baseline, (2) received any amount of study treatment, and (3) had at least one post baseline disease assessment or discontinued due to clinical progression, toxicity, or death. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Number | 90% Confidence Interval | Percentage of participants | From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first (maximum up to 17.8 months) |
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| Secondary | Confirmed Objective Response Rate(cORR) Per RECIST Version 1.1 Determined by ICR: All Participants | cORR was defined as percentage of participants with confirmed CR or PR, per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Participants with missing data were considered non-responders. cORR was determined by ICR. Two-sided 90% exact confidence interval was based on Clopper-Pearson method. | Not Posted | Dec 2028 | From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first | Participants | ||||||||||||||||||||||||||||||
| Secondary | Confirmed Objective Response Rate(cORR) Per RECIST Version 1.1 Determined by Investigator Assessment (INV): Japanese Participants | cORR was defined as percentage of participants with confirmed CR or PR, per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Participants with missing data were considered non-responders. cORR was determined by INV. Two-sided 90% exact confidence interval was based on Clopper-Pearson method. | Not Posted | Dec 2028 | From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first | Participants | ||||||||||||||||||||||||||||||
| Secondary | Confirmed Objective Response Rate(cORR) Per RECIST Version 1.1 Determined by INV: All Participants | cORR was defined as percentage of participants with confirmed CR or PR, per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Participants with missing data were considered non-responders. cORR was determined by ICR. Two-sided 90% exact confidence interval was based on Clopper-Pearson method. | Not Posted | Dec 2028 | From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first | Participants | ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) Per RECIST Version 1.1 Determined by INV: All Participants | DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to documented PD per RECIST version 1.1 or death from any cause, whichever occurred first. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Only those participants who achieved a confirmed response will be included in the analysis. DOR was determined by INV. | Not Posted | Dec 2028 | From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first | Participants | ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) Per RECIST Version 1.1 Determined by INV: Japanese Participants | DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to documented PD per RECIST version 1.1 or death from any cause, whichever occurred first. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Only those participants who achieved a confirmed response will be included in the analysis. DOR was determined by INV. | Not Posted | Dec 2028 | From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first | Participants | ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) Per RECIST Version 1.1 Determined by ICR: All Participants | DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to documented PD per RECIST version 1.1 or death from any cause, whichever occurred first. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Only those participants who achieved a confirmed response will be included in the analysis. DOR was determined by ICR. | Not Posted | Dec 2028 | From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first | Participants | ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) Per RECIST Version 1.1 Determined by ICR: Japanese Participants | DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to documented PD per RECIST version 1.1 or death from any cause, whichever occurred first. CR: disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR: a >=30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters. Only response assessments before first documented PD or new anti-cancer therapies were considered. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. Only those participants who achieved a confirmed response will be included in the analysis. DOR was determined by ICR. | Not Posted | Dec 2028 | From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first | Participants | ||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) Per RECIST Version 1.1 Determined by ICR: All Participants | PFS time was defined as the time from the first date of study treatment to the date of documented disease progression using RECIST v1.1 or death from any cause, whichever occurred first. Participants who were alive and had not progressed at the time of the analysis were censored at the time of their last tumor assessment documenting absence of PD. Participants lacking an evaluation of tumor response after their start of study treatment had their event time censored at 1 day. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. PFS was determined by ICR. | Not Posted | Dec 2028 | From date of first dose to the date of documented disease progression or death from any cause whichever occurred first or censoring date | Participants | ||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) Per RECIST Version 1.1 Determined by ICR: Japanese Participants | PFS time was defined as the time from the first date of study treatment to the date of documented disease progression using RECIST v1.1 or death from any cause, whichever occurred first. Participants who were alive and had not progressed at the time of the analysis were censored at the time of their last tumor assessment documenting absence of PD. Participants lacking an evaluation of tumor response after their start of study treatment had their event time censored at 1 day. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. PFS was determined by ICR. | Not Posted | Dec 2028 | From date of first dose to the date of documented disease progression or death from any cause whichever occurred first or censoring date | Participants | ||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) Per RECIST Version 1.1 Determined by INV: All Participants | PFS time was defined as the time from the first date of study treatment to the date of documented disease progression using RECIST v1.1 or death from any cause, whichever occurred first. Participants who were alive and had not progressed at the time of the analysis were censored at the time of their last tumor assessment documenting absence of PD. Participants lacking an evaluation of tumor response after their start of study treatment had their event time censored at 1 day. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. PFS was determined by INV. | Not Posted | Dec 2028 | From date of first dose to the date of documented disease progression or death from any cause whichever occurred first or censoring date | Participants | ||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) Per RECIST Version 1.1 Determined by INV: Japanese Participants | PFS time was defined as the time from the first date of study treatment to the date of documented disease progression using RECIST v1.1 or death from any cause, whichever occurred first. Participants who were alive and had not progressed at the time of the analysis were censored at the time of their last tumor assessment documenting absence of PD. Participants lacking an evaluation of tumor response after their start of study treatment had their event time censored at 1 day. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions was also considered PD. PFS was determined by INV. | Not Posted | Dec 2028 | From date of first dose to the date of documented disease progression or death from any cause whichever occurred first or censoring date | Participants | ||||||||||||||||||||||||||||||
| Secondary | Overall Survival: All Participants | OS was defined as the time from start of study treatment to date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. Participants lacking data beyond their start of study treatment had their survival time censored at 1 day. | Not Posted | Dec 2028 | From start of study treatment to date of death from any cause or censoring date | Participants | ||||||||||||||||||||||||||||||
| Secondary | Overall Survival: Japanese Participants | OS was defined as the time from start of study treatment to date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. Participants lacking data beyond their start of study treatment had their survival time censored at 1 day. | Not Posted | Dec 2028 | From start of study treatment to date of death from any cause or censoring date | Participants | ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events, Serious Adverse Events and Treatment Related Adverse Events and Serious Adverse Events: All Participants | An adverse event was defined as any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Serious adverse event was any untoward medical occurrence at any dose that resulted in death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect or that was considered as an important medical event. Treatment related adverse events and serious adverse events was judged by investigator. | Not Posted | Dec 2028 | From date of first dose of study treatment to up to 30 days after last dose of study treatment | Participants | ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events, Serious Adverse Events and Treatment Related Adverse Events and Serious Adverse Events: Japanese Participants | An adverse event was defined as any untoward medical occurrence in a participant or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. t intervention indicated and Grade 5 indicates death related to AE. Participants who discontinued treatment due to AEs were captured under AEs leading to treatment discontinuation. SAE was any untoward medical occurrence at any dose that resulted in death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect or that was considered as an important medical event. Treatment related adverse events and serious adverse events was judged by investigator. | Not Posted | Dec 2028 | From date of first dose of study treatment to up to 30 days after last dose of study treatment | Participants | ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormalities in Laboratory Parameters: All Participants | Not Posted | Dec 2028 | From date of first dose of study treatment to up to 30 days after last dose of study treatment | Participants | |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormalities in Laboratory Parameters: Japanese Participants | Not Posted | Dec 2028 | From date of first dose of study treatment to up to 30 days after last dose of study treatment | Participants | |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Dose Modifications and Treatment Discontinuations: All Participants | Not Posted | Dec 2028 | From date of first dose of study treatment to up to 30 days after last dose of study treatment | Participants | |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Dose Modifications and Treatment Discontinuations: Japanese Participants | Not Posted | Dec 2028 | From date of first dose of study treatment to up to 30 days after last dose of study treatment | Participants | |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Vital Signs: All Participants | Not Posted | Dec 2028 | From date of first dose of study treatment to up to 30 days after last dose of study treatment | Participants | |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Vital Signs: Japanese Participants | Not Posted | Dec 2028 | From date of first dose of study treatment to up to 30 days after last dose of study treatment | Participants |
From date of first dose of study treatment up to 30 days after last dose of study treatment, death date, or data cut-off date, whichever is earlier (up to 24.6 months)
Same event may appear as both non-SAE and SAE, but 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.
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 | Tucatinib + Capecitabine + Trastuzumab | Participants with locally advanced unresectable or metastatic HER2+ breast cancer who have had prior treatment with taxane anti-cancer agent, trastuzumab, pertuzumab, and trastuzumab emtansine (T-DM1) were administered Tucatinib 300 mg tablets orally BID, Capecitabine tablets 1000 mg/m^2 orally BID on Days 1 to 14 of each 21-day cycle and Trastuzumab was administered as a loading dose of 8 mg/kg IV followed by 6 mg/kg once every 21 days until unacceptable toxicity, disease progression, death, withdrawal of consent, or study closure. | 15 | 66 | 6 | 66 | 65 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal 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 |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Diarrhoea | 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 |
| |
| 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 |
| |
| Pyrexia | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary 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 |
| |
| Paronychia | Infections and infestations | MedDRA v26.0 | Systematic Assessment |
| |
| Accidental overdose | 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 bilirubin increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Headache | Nervous system 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 |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications 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. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 14, 2023 | Jul 15, 2024 | 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 |
| D000068878 | Trastuzumab |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| 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 |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided