Actively Recruiting
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)
Led by University of Southern California · Updated on 2026-03-10
65
Participants Needed
3
Research Sites
25 weeks
Total Duration
On this page
Sponsors
U
University of Southern California
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
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, HER2/neu-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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and ability to follow study procedures
- Both males and females aged 18 years or older
- Clinical diagnosis of metastatic triple negative or hormone resistant, HER2/neu-negative breast cancer (Phase I)
- Life expectancy of at least 6 months (Phase I)
- Previous chemotherapy completed at least 3 weeks before study drug
- TNBC diagnosis confirmed histologically with ER/PR positivity <10% and HER2/neu-negative (Phase II and Parallel Baseline Arm)
- Stage I to III breast cancer with less than complete pathologic response after neoadjuvant therapy (Phase II and Parallel Baseline Arm)
- No prior systemic breast cancer treatment except neoadjuvant regimen without capecitabine or sarilumab (Phase II and Parallel Baseline Arm)
- ECOG performance status 0 to 2
- Adequate organ function including ANC >1500/mcl, platelets ≥100,000/mcl, hemoglobin ≥9, ALT ≤5x ULN, AST ≤5x ULN, bilirubin ≤3x ULN, GFR ≥30 ml/min
- Women of childbearing potential must use effective contraception during study and 24 weeks after last dose
- Males with partners of childbearing potential must use contraception during study and for 24 weeks after last dose
You will not qualify if you...
- Unwillingness or inability to use contraception during study and 24 weeks after last dose
- Pregnant or breastfeeding females
- Any disease or condition that contraindicates protocol therapy or may affect study results
- Hepatitis B infection (Phase I and II)
- History of tuberculosis injection (Phase I and II)
- History of diverticulitis (Phase I and II)
- Use of live vaccines within 30 days prior to treatment (Phase I and II)
- History of other malignancies with higher risk of recurrence or death than study cancer
- Prisoners or involuntarily incarcerated individuals
- Compulsory detention for psychiatric or physical illness
- Inability to comply with study or follow-up procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks (8 cycles of capecitabine)
Participants receive sarilumab combined with capecitabine in cycles. In Phase I, sarilumab is given as 4 doses every 3 weeks alongside the first 4 of 8 cycles of capecitabine. In Phase II, sarilumab dose is based on Phase I results and combined with the first 4 of 8 cycles of capecitabine. Capecitabine is taken twice daily for 14 days every 21 days.
1 visit every 3 weeks during treatment cycles
Trial Site Locations
Total: 3 locations
1
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
UF Health
Gainesville, Florida, United States, 32610
Active, Not Recruiting
Research Team
K
Kimberly Arieli, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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