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T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer — T-DM1  

Breast Cancer Clinical Trial

Official title:
A Single Arm Phase II Study to Evaluate Efficacy of T-DM1 With Palbociclib in the Treatment of Patients With Metastatic HER2 Positive Breast Cancer

Clinical Trial Summary

This is a single arm, phase II study to evaluate if the combination of T-DM1 with palbociclib improves progression-free survival in patients with metastatic HER2 positive breast cancer. All patients will be treated with T-DM1 with palbociclib.

Clinical Trial Description

This is a multi-center, single arm, phase II study of T-DM1 with palbociclib in the treatment of patients with metastatic HER2-positive breast cancer. Hypotheses: Combination of T-DM1 with palbociclib improves progression free survival Primary objective: Progression free survival of the combination of T-DM1 with palbociclib Secondary objectives i) Response rates ii) Overall survival Correlative objectives i) Investigate predictive biomarkers of response in blood and archived tumor tissue ii) Investigate mechanisms of resistance for palbociclib in blood and tumor tissue ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03530696
Study type Interventional
Source University of Arizona
Contact
Status Completed
Phase Phase 2
Start date December 6, 2018
Completion date December 22, 2022
View Details
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