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
344 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
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.
CONDITIONS
Official 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 comply with study procedures
- Male or female aged 18 years or older
- Clinical diagnosis of metastatic triple negative or hormone resistant, HER2/neu-negative breast cancer confirmed histologically (Phase I)
- Life expectancy of at least 6 months (Phase I)
- At least 3 weeks since any prior cytotoxic chemotherapy; prior capecitabine allowed if not immediate prior treatment (Phase I)
- Diagnosis of triple negative breast cancer confirmed histologically with ER/PR positivity <10% and HER2/neu-negative (Phase II and Parallel Baseline Arm)
- Pathologic confirmation of stage I-III breast cancer with less than complete pathologic response after neoadjuvant therapy (Phase II and Parallel Baseline Arm)
- No prior systemic treatment for breast cancer except neoadjuvant regimen excluding capecitabine or sarilumab (Phase II and Parallel Baseline Arm)
- ECOG Performance Status 0-2
- Adequate organ function including ANC >1500/mcl, platelets ≥100,000/mcl, hemoglobin ≥9, ALT ≤5x ULN, AST ≤5x ULN, bilirubin ≤3x ULN, and GFR ≥30 ml/min
- Women of childbearing potential must use highly effective contraception during study and for 24 weeks after last dose
- Males with female partners of childbearing potential must use physician-approved contraception during study and for 24 weeks after last dose
You will not qualify if you...
- Unwilling or unable to use contraception during study and for 24 weeks after last dose if of childbearing potential
- Pregnant or breastfeeding females
- Any disease or condition that contraindicates study therapy or poses high risk for complications as judged by physician
- Hepatitis B infection except prior vaccination (Phase I and II)
- History of tuberculosis infection (Phase I and II)
- History of diverticulitis (Phase I and II)
- Use of live vaccines within 30 days prior to study treatment (Phase I and II)
- History of other malignancy with higher risk of recurrence or death than study cancer
- Prisoners or involuntarily incarcerated individuals
- Those compulsorily detained for psychiatric or physical illness treatment
- Inability to comply with study and follow-up procedures
AI-Screening
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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
CONTACT
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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