Pembrolizumab and Oral Metronomic Cyclophosphamide in Patients With Chest Wall Breast Cancer
Status:
Not yet recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
This is a Phase II single center, open-label, non-randomized study in patients with locally
recurrent, inoperable, and/or metastatic inflammatory breast cancer with lymphangitic spread
to the chest wall. Patients will be treated with pembrolizumab administered as an intravenous
infusion at 200 mg in 21-day treatment cycles and oral cyclophosphamide (CTX) 50 mg per day
in metronomic administration as a 21 days cycle Forty-six patients will be required for the
study. Key inclusion criteria are PDL1 (≥1%) positive and/or tumor infiltrating lymphocyte
positive (≥1%) locally advanced "chest wall" breast cancer (with or without distant
metastases), who have been treated with chemotherapy or radiation therapy may be eligible for
this study. Patients with cutaneous metastases only (with or without evidence of primary
tumor) are eligible for the study. Key exclusion criteria included prior anti PD1 or anti
CTLA-4 or other immune pathway-targeted therapy. Patients with autoimmune diseases and/or
receiving drugs who interfere with the immune system will not be eligible.