A Pilot and Phase II Study to Assess the Safety, Tolerability and Efficacy of Pembrolizumab Plus Chemotherapy in Metastatic Triple Negative Breast Cancer Patients

The goal of this study is to establish the safety and tolerability of pembrolizumab when administered in combination with either of two chemotherapy regimens (weekly paclitaxel or capecitabine) in unresectable/metastatic triple negative breast cancer (MTNBC) patients.

Inclusion Criteria:
•HER2-negative breast cancer (defined by immunohistochemistry (IHC) 0-1 (or) IHC 2 and in situ hybridization
•(ISH) HER2 / centromere on chromosome 17 (CEP17) < 2.0)ER and PR-negative breast cancer (defined by IHC<1%)
•Measurable metastatic or unresectable disease based on response evaluation criteria in solid tumors (RECIST) 1.1.
•Indicated for treatment with either weekly paclitaxel or oral capecitabine, as first or second-line chemotherapy in the metastatic/unresectable setting (as determined by the consenting investigator);
•Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained during screening. Archival tissue is acceptable if no intervening anti-neoplastic therapy has been administered, and if sufficient material is available for analysis

NOTE: Capecitabine cohort is now closed to enrollment
David Page, M.D.
Earle A Chiles Research Institute (EACRI)
Nikki Moxon
  • Cedar Sinai
  • Oncology and Hematology Care Eastside
  • Oncology and Hematology Care Westside