A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer
Status:
Terminated
Trial end date:
2019-04-17
Target enrollment:
Participant gender:
Summary
This is a Phase 1b, open-label, multicenter study to determine the Maximum Tolerated Dose
(MTD) or Maximum Administered Dose (MAD) of poziotinib when administered with standard dosing
of T-DM1 (3.6 mg/kg IV on Day 1 of each 21-day cycle) in women with advanced or metastatic
HER2+ breast cancer. The poziotinib dose identified in Part 1 of the study will be used in
combination with standard dose of T-DM1 in Part 2 of the study to confirm the poziotinib dose
and evaluate the preliminary efficacy of the combination therapy.