A Phase II Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients: Big Ten Cancer Research Consortium BTCRC-BRE16-042
Categories (click each to see list of all clinical trials associated with that category): Breast (ONC)
Current Status: Open
Phase: II
Principal Investigator: Krishnamurthy, Jairam
Contact Information:
Shara Graalfs
+1 402-596-3151
shara.graalfs@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT03393845#eligibility
Summary
This is a non-randomized, multi-site, open-label Phase II trial for subjects with metastatic, hormone receptor positive, HER2 negative breast cancer. The study will enroll 47 patients to evaluate the anti-tumor activity of pembrolizumab with fulvestrant as measured by RECIST 1.1 tumor response and by progression free survival. We expect that if the immune response is augmented by the addition of pembrolizumab, significant change in durability of response will be noted.
Patients will be treated with pembrolizumab dosed at 200 mg intravenous infusion in combination with standard fulvestrant 500mg intramuscular injection.