Breast CancerPhase 2NCT04721977
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)
A Phase 2 study testing Tucatinib, Trastuzumab and Capecitabine in people with Breast Cancer, run by Pfizer at 28 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tucatinib, Trastuzumab and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 28 sitesin 3 countries
- Study dates
- 8 Apr 2021to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has histologically confirmed HER2+ breast carcinoma
- Has received previous treatment with taxane anti-cancer agent, trastuzumab, pertuzumab, and T-DM1 with the exception of when the use of taxanes is contraindicated or judged not to be the best treatment at the investigator's discretion
- Has radiographically and/or histologically confirmed disease progression on last systemic anticancer treatment
- Has adequate organ function
- Female participant is not pregnant or breastfeeding and is not a woman of childbearing potential (WOCBP) or is a WOCBP and using contraception or abstinent from heterosexual intercourse during the intervention period and for at least 30 days after receiving the last dose of tucatinib, 80 days after receiving the last dose of trastuzumab, or 180 days after receiving the last dose of capecitabine, whichever occurs last and agrees to not donate eggs during this period
- Male participants refrain from donating sperm and are either abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after receiving the last dose of tucatinib and 90 days after receiving the last dose of capecitabine, whichever occurs last
- Previously treated brain metastasis is stable or progressed, provided there is no clinical indication for immediate re-treatment
Who cannot join
- Has been previously treated with lapatinib within 12 months of starting study treatment
- Has been previously treated with neratinib, afatinib, tucatinib or capecitabine
- Has a history of exposure to doxorubicin, epirubicin, mitoxantrone, idarubicin, liposomal doxorubicin
- Has had treatment with any systemic anti-cancer therapy including hormonal therapy, non-central nervous system (CNS) radiation or experimental agent ≤3 weeks before first dose of study treatment
- Has any toxicity related to prior cancer therapies that has not resolved with the exception of alopecia, congestive heart failure, anemia
- Has clinically significant cardiopulmonary disease
Show all 15Show fewer
- Has known myocardial infarction or unstable angina within 6 months prior to the first dose of study treatment
- Has any uncontrolled viral, bacterial or fungal infection within 14 days prior to the first dose of study treatment
- Is positive for Hepatitis B, Hepatitis C or has known chronic liver disease
- Is known to be positive for human immunodeficiency virus (HIV)
- Has evidence within 2 years of the start of study treatment of another malignancy that required systemic treatment
- Has ongoing use of systemic corticosteroids for control of symptoms of brain metastases
- Has any brain lesion thought to require immediate local therapy
- Has known or suspected leptomeningeal disease (LMD)
- Has poorly controlled generalized or complex partial seizures or manifest neurologic progression due to brain metastases
Trial locations and contacts
28 sites in 3 countries.
28 sites in 3 countries
Japan24 sites
Hyogo Cancer Center ( Site 1005)
Akashi, Hyōgo, 673-8558
National Hospital Organization Kyushu Cancer Center ( Site 1009)
Fukuoka, 811-1395
Fukushima Medical University Hospital ( Site 1012)
Fukushima, 960-1295
Hiroshima City Hiroshima Citizens Hospital ( Site 1024)
Hiroshima, 730-8518
Social medical corporation Hakuaikai Sagara Hospital ( Site 1008)
Kagoshima, 892-0833
National Cancer Center Hospital East ( Site 1002)
Kashiwa, Chiba, 2778577
Saitama Cancer Center ( Site 1018)
Kitaadachi-gun, Saitama, 362-0806
Kumamoto Shinto General Hospital ( Site 1007)
Kumamoto, 862-8655
National Hospital Organization Shikoku Cancer Center ( Site 1014)
Matsuyama, Ehime, 791-0280
Aichi Cancer Center Hospital ( Site 1013)
Nagoya, Aichi-ken, 464-8681
Nagoya University Hospital ( Site 1021)
Nagoya, Aichi-ken, 466-8560
Medical Corporation Nahanishikai Nahanishi Clinic ( Site 1016)
Naha, Okinawa, 901-0154
Hyogo College of Medicine Hospital ( Site 1019)
Nishinomiya, Hyōgo, 663-8501
National Hospital Organization Osaka National Hospital ( Site 1001)
Osaka, 540-0006
Osaka International Cancer Institute ( Site 1004)
Osaka, 541-8567
National Hospital Organization Hokkaido Cancer Center ( Site 1017)
Sapporo, Hokkaido, 003-0804
Hokkaido University Hospital ( Site 1022)
Sapporo, Hokkaido, 060-8648
National Cancer Center Hospital ( Site 1003)
Tokyo, 104-0045
Juntendo University Hospital ( Site 1025)
Tokyo, 113-0033
The Cancer Institute Hospital of JFCR ( Site 1015)
Tokyo, 135-8550
Showa University Hospital ( Site 1023)
Tokyo, 142-8666
Tokyo Medical University Hospital ( Site 1006)
Tokyo, 160-0023
University of Tsukuba Hospital ( Site 1020)
Tsukuba, Ibaraki, 305-8576
Kanagawa Cancer Center ( Site 1010)
Yokohama, Kanagawa, 241-8515
South Korea3 sites
Seoul National University Hospital ( Site 2003)
Seoul, 03080
Severance Hospital ( Site 2001)
Seoul, 03722
Samsung Medical Center ( Site 2002)
Seoul, 06351
Taiwan1 site
National Cheng Kung University Hospital ( Site 3000)
Dawan, Tainan, 704
About this study
Official title: A Phase 2 Open-label, Single Arm Study of MK-7119 in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic HER2+ Breast Carcinoma
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%.
- Conditions
- Breast Cancer
- Being tested
- Tucatinib, Trastuzumab, Capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TucatinibDrug
Also called MK-7119, Tukysa
Tucatinib 300 mg administered BID via oral tablet
TrastuzumabBiological
Also called Herceptin, Herceptin Hylecta
Trastuzumab 8 mg/kg loading dose followed by 6 mg/kg maintenance dose, administered via IV infusion
CapecitabineDrug
Also called Xeloda
Capecitabine 1000 mg/m^2 administered BID via oral tablet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tucatinib; Biological: Trastuzumab; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Secondary outcomes (21)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From date of first dose of study treatment to up to 30 days after last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start8 Apr 2021
- Primary completion17 Jul 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721977
- Sponsor's protocol ID
- 7119-001
- Other IDs
- MK-7119-001, jRCT2051200152, C4251013
- Status last verified
- Aug 2026
- First submitted
- 20 Jan 2021
- Last updated
- 10 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-label, Single Arm Study of MK-7119 in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic HER2+ Breast Carcinoma
- ClinicalTrials.gov ID
- NCT04721977
- Acronym / sponsor ID
- 7119-001
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jan 2021 (actual)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tucatinib + Trastuzumab + Capecitabine | Experimental | Drug: Tucatinib, Biological: Trastuzumab, Drug: CapecitabineParticipants 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has histologically confirmed HER2+ breast carcinoma
- Has received previous treatment with taxane anti-cancer agent, trastuzumab, pertuzumab, and T-DM1 with the exception of when the use of taxanes is contraindicated or judged not to be the best treatment at the investigator's discretion
- Has radiographically and/or histologically confirmed disease progression on last systemic anticancer treatment
- Has adequate organ function
- Female participant is not pregnant or breastfeeding and is not a woman of childbearing potential (WOCBP) or is a WOCBP and using contraception or abstinent from heterosexual intercourse during the intervention period and for at least 30 days after receiving the last dose of tucatinib, 80 days after receiving the last dose of trastuzumab, or 180 days after receiving the last dose of capecitabine, whichever occurs last and agrees to not donate eggs during this period
Key exclusion criteria (15 listed)
- Has been previously treated with lapatinib within 12 months of starting study treatment
- Has been previously treated with neratinib, afatinib, tucatinib or capecitabine
- Has a history of exposure to doxorubicin, epirubicin, mitoxantrone, idarubicin, liposomal doxorubicin
- Has had treatment with any systemic anti-cancer therapy including hormonal therapy, non-central nervous system (CNS) radiation or experimental agent ≤3 weeks before first dose of study treatment
- Has any toxicity related to prior cancer therapies that has not resolved with the exception of alopecia, congestive heart failure, anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TucatinibAlso: MK-7119, TukysaTucatinib 300 mg administered BID via oral tablet | Drug | Tucatinib + Trastuzumab + Capecitabine |
| TrastuzumabAlso: Herceptin, Herceptin HylectaTrastuzumab 8 mg/kg loading dose followed by 6 mg/kg maintenance dose, administered via IV infusion | Biological | Tucatinib + Trastuzumab + Capecitabine |
| CapecitabineAlso: XelodaCapecitabine 1000 mg/m^2 administered BID via oral tablet | Drug | Tucatinib + Trastuzumab + Capecitabine |
Primary outcome
Confirmed Objective Response Rate(cORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Determined by Independent Central Review (ICR): Japanese Participants
Time frame: 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.
21 secondary outcomes
Confirmed Objective Response Rate(cORR) Per RECIST Version 1.1 Determined by ICR: All Participants
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From start of study treatment to date of death from any cause or censoring date
Overall Survival: Japanese Participants
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From date of first dose of study treatment to up to 30 days after last dose of study treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
28 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tucatinib, Trastuzumab and Capecitabine in people with Breast Cancer, run by Pfizer at 28 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Japan, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed Objective Response Rate(cORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Determined by Independent Central Review (ICR): Japanese Participants (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.