OncoMatch/Clinical Trials/NCT03971045
Pembrolizumab and Oral Metronomic Cyclophosphamide in Patients With Chest Wall Breast Cancer
Is NCT03971045 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pembrolizumab for breast cancer.
Treatment: Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) overexpression (≥1%) (≥1%)
PDL1 (≥1%) positive
Allowed: ESR1 expression
Patients with hormone receptor-positive...breast cancer would be eligible for the study only if their disease is considered refractory to hormonal...agents, respectively, and no further hormonal...treatment is indicated
Allowed: HER2 (ERBB2) overexpression
Patients with...HER2-positive breast cancer would be eligible for the study only if their disease is considered refractory to...anti-HER2 agents, respectively, and no further...anti-HER2 treatment is indicated
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy
who have been treated with chemotherapy or radiation therapy may be eligible for this study
Must have received: radiation therapy
who have been treated with chemotherapy or radiation therapy may be eligible for this study
Cannot have received: anti-PD-1/PD-L1/PD-L2 agent
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
Cannot have received: anti-cancer monoclonal antibody
Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1
Cannot have received: chemotherapy
Exception: within 2 weeks prior to study Day 1
Has had prior chemotherapy...within 2 weeks prior to study Day 1
Cannot have received: targeted small molecule therapy
Exception: within 2 weeks prior to study Day 1
Has had prior...targeted small molecule therapy...within 2 weeks prior to study Day 1
Cannot have received: radiation therapy
Exception: within 2 weeks prior to study Day 1
Has had prior...radiation therapy within 2 weeks prior to study Day 1
Lab requirements
Blood counts
Demonstrate adequate organ function as defined in protocol, all screening labs should be performed within 10 days of treatment initiation
Kidney function
Demonstrate adequate organ function as defined in protocol, all screening labs should be performed within 10 days of treatment initiation
Liver function
Demonstrate adequate organ function as defined in protocol, all screening labs should be performed within 10 days of treatment initiation
Demonstrate adequate organ function as defined in protocol, all screening labs should be performed within 10 days of treatment initiation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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