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)

This study looks to advance a novel and potent strategy to eliminate minimal residual disease (MRD) in triple negative breast cancer (TNBC) present even after multimodal treatment, thereby improving survival and increasing cure rate in this aggressive cancer. Patients with locally advanced TNBC are at high risk of developing lethal metastatic disease within 2 years of diagnosis, especially for those without a pathologic complete response (pCR) after neoadjuvant chemotherapy. The high risk occurs despite surgical excision of the primary tumor and axillary lymph nodes to eliminate residual disease.

NCT Number	NCT04333706
Lead Sponsor	University of Southern California Collaborators: National Cancer Institute (NCI)
Conditions	Breast, Metastatic, Triple Negative, Cancer, Disseminated Tumor Cell
Enrollment	65 participants
Start Date	2020-09-26
Primary Completion	2026-11-03 (estimated)
Study Completion	2027-05-03 (estimated)
Updated on ClinicalTrials.gov	2026-03-10