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=70). There will be two cohorts of patients consisting of a triple negative breast cancer (TNBC) cohort with 50 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. The HR+ cohort of this trial is now closed to enrollment. The cohort enrolling patients with hormone receptor-positive tumors (ER and/or PR positive) has completed enrollment. The only cohort currently enrolling is for patients with triple-negative cancers. Patients with tumors expressing low levels of estrogen/progesterone receptors (ER/PR<5%) are also eligible for this cohort.




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