At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Tucatinib, Trastuzumab, and 1 other intervention for Breast Cancer. Active but no longer recruiting, targeting 66 participants across 28 sites in 3 countries.
Detailed 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%.
Study Details
Timeline
Interventions
Tucatinib 300 mg administered BID via oral tablet
Trastuzumab 8 mg/kg loading dose followed by 6 mg/kg maintenance dose, administered via IV infusion
Capecitabine 1000 mg/m\^2 administered BID via oral tablet