Trial · NCT04721977
A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001)
NCT04721977, Phase 2, Active not recruiting, Pfizer; results first posted 2024-08-09
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001). Trials, record NCT04721977. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04721977
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001)
- NCT number
- NCT04721977
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 66 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Breast Cancer
- Interventions
- Tucatinib, Trastuzumab, Capecitabine
- First posted
- 2021-01-25
- Last updated
- 2026-09-10
- Results first posted
- 2024-08-09
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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) | 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. |
| Secondary | Confirmed Objective Response Rate(cORR) Per RECIST Version 1.1 Determined by ICR: All Participants | From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first | 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. |
| Secondary | Confirmed Objective Response Rate(cORR) Per RECIST Version 1.1 Determined by Investigator Assessment (INV): Japanese Participants | From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first | 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. |
| Secondary | Confirmed Objective Response Rate(cORR) Per RECIST Version 1.1 Determined by INV: All Participants | From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first | 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. |
| Secondary | Duration of Response (DOR) Per RECIST Version 1.1 Determined by INV: All Participants | From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first | 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. |
| Secondary | Duration of Response (DOR) Per RECIST Version 1.1 Determined by INV: Japanese Participants | From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first | 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. |
| Secondary | Duration of Response (DOR) Per RECIST Version 1.1 Determined by ICR: All Participants | From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first | 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. |
| Secondary | Duration of Response (DOR) Per RECIST Version 1.1 Determined by ICR: Japanese Participants | From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first | 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. |
| Secondary | Progression Free Survival (PFS) Per RECIST Version 1.1 Determined by ICR: All Participants | From date of first dose to the date of documented disease progression or death from any cause whichever occurred first or censoring date | 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. |
| Secondary | Progression Free Survival (PFS) Per RECIST Version 1.1 Determined by ICR: Japanese Participants | From date of first dose to the date of documented disease progression or death from any cause whichever occurred first or censoring date | 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. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | 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) | 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. | Percentage of participants | NUMBER |
| SECONDARY | Confirmed Objective Response Rate(cORR) Per RECIST Version 1.1 Determined by ICR: All Participants | From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first | |||
| SECONDARY | Confirmed Objective Response Rate(cORR) Per RECIST Version 1.1 Determined by Investigator Assessment (INV): Japanese Participants | From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first | |||
| SECONDARY | Confirmed Objective Response Rate(cORR) Per RECIST Version 1.1 Determined by INV: All Participants | From date of first dose until first documented disease progression or start of new anticancer therapy, whichever occurred first | |||
| SECONDARY | Duration of Response (DOR) Per RECIST Version 1.1 Determined by INV: All Participants | From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first | |||
| SECONDARY | Duration of Response (DOR) Per RECIST Version 1.1 Determined by INV: Japanese Participants | From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first | |||
| SECONDARY | Duration of Response (DOR) Per RECIST Version 1.1 Determined by ICR: All Participants | From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first | |||
| SECONDARY | Duration of Response (DOR) Per RECIST Version 1.1 Determined by ICR: Japanese Participants | From date of first objective response (CR or PR that is subsequently confirmed) to documented PD, or death from any cause whichever occurred first | |||
| SECONDARY | Progression Free Survival (PFS) Per RECIST Version 1.1 Determined by ICR: All Participants | From date of first dose to the date of documented disease progression or death from any cause whichever occurred first or censoring date | |||
| SECONDARY | Progression Free Survival (PFS) Per RECIST Version 1.1 Determined by ICR: Japanese Participants | From date of first dose to the date of documented disease progression or death from any cause whichever occurred first or censoring date |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Confirmed Objective Response Rate(cORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Determined by Independent Central Review (ICR): Japanese Participants | Tucatinib + Capecitabine + Trastuzumab | 35.4 | 90% Confidence Interval 24.0 to 48.3 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tucatinib + Capecitabine + Trastuzumab | 66 | |
| Overall Study | Japanese Participants | Tucatinib + Capecitabine + Trastuzumab | 53 | |
| Overall Study | COMPLETED | Tucatinib + Capecitabine + Trastuzumab | 0 | |
| Overall Study | NOT COMPLETED | Tucatinib + Capecitabine + Trastuzumab | 66 |
Source ClinicalTrials.gov
Adverse events44
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Tucatinib + Capecitabine + Trastuzumab | 13 | 66 | 16 |
| other | Abdominal pain upper | Gastrointestinal disorders | Tucatinib + Capecitabine + Trastuzumab | 6 | 66 | 6 |
| other | Cheilitis | Gastrointestinal disorders | Tucatinib + Capecitabine + Trastuzumab | 4 | 66 | 4 |
| other | Constipation | Gastrointestinal disorders | Tucatinib + Capecitabine + Trastuzumab | 6 | 66 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | Tucatinib + Capecitabine + Trastuzumab | 40 | 66 | 57 |
| other | Nausea | Gastrointestinal disorders | Tucatinib + Capecitabine + Trastuzumab | 32 | 66 | 41 |
| other | Stomatitis | Gastrointestinal disorders | Tucatinib + Capecitabine + Trastuzumab | 18 | 66 | 19 |
| other | Vomiting | Gastrointestinal disorders | Tucatinib + Capecitabine + Trastuzumab | 9 | 66 | 14 |
| other | Fatigue | General disorders | Tucatinib + Capecitabine + Trastuzumab | 9 | 66 | 13 |
| other | Malaise | General disorders | Tucatinib + Capecitabine + Trastuzumab | 13 | 66 | 18 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tucatinib + Capecitabine + Trastuzumab | 15 | 66 |
| Total, other adverse events | Tucatinib + Capecitabine + Trastuzumab | 65 | 66 |
| Total, serious adverse events | Tucatinib + Capecitabine + Trastuzumab | 6 | 66 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04721977
GET https://conductscience.org/api/trials/v1/NCT04721977/registered?page=2