Tucatinib+Trastuzumab+Eribulin in HER2+ MBC
Trial Parameters
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the three-drug combination of tucatinib, trastuzumab, and eribulin in patients with de novo and recurrent unresectable metastatic HER-2/neu positive breast cancer as assessed by ORR, PFS and OS after prior treatment with a taxane, trastuzumab, and T-DM1.
Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed HER2+ breast carcinoma, with HER2+ defined by in situ hybridization (ISH) or fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) 2. Have received previous treatment with trastuzumab deruxtecan in the metastatic setting or have recurred within 6 months of receiving this treatment in the adjuvant or neoadjuvant setting. Prior taxane, capecitabine and T-DM1 are not required. Prior tucatinib therapy is allowed. Patients for whom Trastuzumab is contraindicated are not permitted. Have progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy (as confirmed by site investigator),or be intolerant of last systemic therapy. 3. Have measurable or non-measurable disease assessable by RECIST 1.1 4. Be at least 18 years of age at time of consent. 5. Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0,1 or 2 6. Have a life expectancy of at least 6 months, in the opinion of