Actively Recruiting
Phase 1 Dose Finding Study of Sarilumab Plus Capecitabine in HER2Neu-Negative Metastatic Breast Cancer and Phase 2 Single-Arm Study of Sarilumab Plus Capecitabine in Stage I-III Triple Negative Breast Cancer with High-Risk Residual Disease
Led by University of Southern California · Updated on 2026-03-10
65
Participants Needed
3
Research Sites
25 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach to eliminate minimal residual disease MRD in patients with triple negative breast cancer TNBC that remains after multiple treatments. This aggressive cancer type often leads to lethal metastatic disease within 2 years, especially in patients without a complete tumor response after initial chemotherapy. The study aims to improve survival and cure rates by addressing residual cancer cells despite surgery and chemotherapy. The study has two phases. Phase I involves patients with metastatic TNBC or hormone-resistant, HER2neu-negative breast cancer receiving escalating doses of sarilumab combined with capecitabine chemotherapy. Sarilumab is given subcutaneously every 3 weeks alongside capecitabine taken twice daily for 14 days in 21-day cycles. Phase II includes patients with stage I to III TNBC with residual disease after neoadjuvant therapy, treated with a combination of sarilumab and capecitabine compared to historical controls receiving capecitabine alone. A parallel baseline arm receives standard capecitabine alone. Blood samples and optional bone marrow samples are collected during treatment. Participants will be monitored through blood tests and other evaluations during treatment cycles lasting up to 14 weeks. Researchers will assess the maximum tolerated dose and dose-limiting toxicities in Phase I and measure changes in circulating and disseminated tumor cells in Phase II. The study does not include masking or randomization. Participants must meet specific health and organ function criteria and agree to contraception requirements if applicable. The total study duration varies by participant, with safety and response closely observed throughout.
CONDITIONS
Brief Title
A Dose Finding Phase 1 of Sarilumab Plus Capecitabine in HER2/Neu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab Plus Capecitabine in Stage I-III Triple Negative Breast Cancer With High-Risk Residual Disease (EMPOWER)
Research Team
K
Kimberly Arieli, RN
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