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 ID: NCT04721977

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-08
• Study Completion Date: 2026-06-30

Brief 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 (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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tucatinib + Trastuzumab + Capecitabine

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.

Group Type: EXPERIMENTAL

Tucatinib

Intervention Type: DRUG

Tucatinib 300 mg administered BID via oral tablet

Trastuzumab

Intervention Type: BIOLOGICAL

Trastuzumab 8 mg/kg loading dose followed by 6 mg/kg maintenance dose, administered via IV infusion

Capecitabine

Intervention Type: DRUG

Capecitabine 1000 mg/m\^2 administered BID via oral tablet

Interventions

Tucatinib

Tucatinib 300 mg administered BID via oral tablet

Intervention Type: DRUG

Trastuzumab

Trastuzumab 8 mg/kg loading dose followed by 6 mg/kg maintenance dose, administered via IV infusion

Intervention Type: BIOLOGICAL

Capecitabine

Capecitabine 1000 mg/m\^2 administered BID via oral tablet

Intervention Type: DRUG

Other Intervention Names

MK-7119; Tukysa; Herceptin; Herceptin Hylecta; Xeloda

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Aichi Cancer Center Hospital ( Site 1013)

Nagoya, Aichi-ken, Japan

Nagoya University Hospital ( Site 1021)

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East ( Site 1002)

Kashiwa, Chiba, Japan

National Hospital Organization Shikoku Cancer Center ( Site 1014)

Matsuyama, Ehime, Japan

National Hospital Organization Hokkaido Cancer Center ( Site 1017)

Sapporo, Hokkaido, Japan

Hokkaido University Hospital ( Site 1022)

Sapporo, Hokkaido, Japan

Hyogo Cancer Center ( Site 1005)

Akashi, Hyōgo, Japan

Hyogo College of Medicine Hospital ( Site 1019)

Nishinomiya, Hyōgo, Japan

University of Tsukuba Hospital ( Site 1020)

Tsukuba, Ibaraki, Japan

Kanagawa Cancer Center ( Site 1010)

Yokohama, Kanagawa, Japan

Medical Corporation Nahanishikai Nahanishi Clinic ( Site 1016)

Naha, Okinawa, Japan

Saitama Cancer Center ( Site 1018)

Kitaadachi-gun, Saitama, Japan

National Hospital Organization Kyushu Cancer Center ( Site 1009)

Fukuoka, , Japan

Fukushima Medical University Hospital ( Site 1012)

Fukushima, , Japan

Hiroshima City Hiroshima Citizens Hospital ( Site 1024)

Hiroshima, , Japan

Social medical corporation Hakuaikai Sagara Hospital ( Site 1008)

Kagoshima, , Japan

Kumamoto Shinto General Hospital ( Site 1007)

Kumamoto, , Japan

National Hospital Organization Osaka National Hospital ( Site 1001)

Osaka, , Japan

Osaka International Cancer Institute ( Site 1004)

Osaka, , Japan

National Cancer Center Hospital ( Site 1003)

Tokyo, , Japan

Juntendo University Hospital ( Site 1025)

Tokyo, , Japan

The Cancer Institute Hospital of JFCR ( Site 1015)

Tokyo, , Japan

Showa University Hospital ( Site 1023)

Tokyo, , Japan

Tokyo Medical University Hospital ( Site 1006)

Tokyo, , Japan

Seoul National University Hospital ( Site 2003)

Seoul, , South Korea

Severance Hospital ( Site 2001)

Seoul, , South Korea

Samsung Medical Center ( Site 2002)

Seoul, , South Korea

National Cheng Kung University Hospital ( Site 3000)

Dawan, Tainan, Taiwan

Countries

Japan; South Korea; Taiwan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

MK-7119-001

Identifier Type: OTHER

Identifier Source: secondary_id

jRCT2051200152

Identifier Type: REGISTRY

Identifier Source: secondary_id

7119-001

Identifier Type: -

Identifier Source: org_study_id