drugset / Trial / NCT04333706
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)
Phase 1/2
Recruiting
65 enrolled
University of Southern California
National Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2020-09-26
- Primary completion
- 2026-11-03
- Completion
- 2027-05-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg | — |
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Sarilumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Sarilumab | Monoclonal antibody | 200 mg | Subcutaneous |