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RECRUITING
NCT04333706
PHASE1/PHASE2

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)

Sponsor: University of Southern California

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

65

Start Date

2020-09-26

Completion Date

2027-05-03

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

DRUG

Capecitabine

Capecitabine 1000 mg BID

COMBINATION_PRODUCT

Sarilumab 150mg or 200 mg plus Capecitabine

Sarilumab 150mg or 200 mg plus Capecitabine 1000 mg BID

COMBINATION_PRODUCT

Sarilumab 150mg plus Capecitabine

Dose escalation schedule of sarilumab. The starting dose for sarilumab is 150 mg SQ every 21 days, given 3 days prior to the first 4 of 8 cycles of capecitabine 1000 mg BID.

Locations (3)

Los Angeles General Medical Center

Los Angeles, California, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

UF Health

Gainesville, Florida, United States