NCT04333706View on ClinicalTrials.gov

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)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

September 26, 2020

Primary Completion Date

September 1, 2026

Study Completion Date

September 1, 2027

Conditions
BreastMetastaticTriple NegativeCancerDisseminated Tumor Cell
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.

Trial Locations (3)

32610

ACTIVE_NOT_RECRUITING

UF Health, Gainesville

90033

RECRUITING

Los Angeles General Medical Center, Los Angeles

RECRUITING

USC/Norris Comprehensive Cancer Center, Los Angeles

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

University of Southern California

OTHER