Phase II Study of Pembrolizumab and Nab-paclitaxel in HER-2 Negative Metastatic Breast Cancer

Brief description of study

The goal of this Phase II study is to evaluate the safety/tolerability and clinical activity of the combination of nab-paclitaxel and the antibody against programmed cell death 1 (PD-1), pembrolizumab, in patients with human epidermal growth factor receptor (HER-2) negative metastatic breast cancer (n=50). There will be two cohorts of patients consisting of a triple negative breast cancer (TNBC) cohort with 30 subjects and a hormone receptor (HR)-positive cohort with 20 subjects. Tumor expression of programmed cell death ligand 1 (PD-L1) is not required for enrollment in the study, but will be assessed as possible predictive marker.  Enrollment of patients with metaplastic breast cancer is encouraged.


Clinical Study Identifier: s15-00441
ClinicalTrials.gov Identifier: NCT02752685
Principal Investigator: Sylvia Adams
Currently Recruiting

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