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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.
Full 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
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55 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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