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)
- Conditions
- Previously treated locally advanced unresectable or metastatic HER2+ breast carcinoma
- Registration Number
- JPRN-jRCT2051200152
- Lead Sponsor
- akamura Sosuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 55
Has histologically confirmed HER2+ breast carcinoma
- Has received previous treatment with trastuzumab, pertuzumab, and T-DM1
- Has radiographically and/or histologically confirmed disease progression on last systemic anticancer treatment for unresectable locally advanced or metastatic HER2+ breast carcinoma
- 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, 7 months 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
- Has been previously treated with lapatinib within 12 months of starting study treatment
- Has been previously treated with neratinib, afatinib, tucatinib or capecitabine for metastatic disease
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ORR per RECIST 1.1 as determined by independent central review in Japanese population.
- Secondary Outcome Measures
Name Time Method - ORR per RECIST 1.1 as determined by independent central review in all participants population.<br>- ORR per RECIST 1.1 as determined by investigator in Japanese population and all participants population.<br>- DOR and PFS per RECIST 1.1 as determined by independent central review and investigator in Japanese population and all participants population.<br>- OS<br>- Safety