Sarilumab and Capecitabine for Breast Cancer
This study is testing a combination of two drugs, Sarilumab and Capecitabine, for breast cancer. It's for people with metastatic (spread) triple-negative or hormone-resistant, HER2/neu-negative breast cancer, or those with early-stage triple-negative breast cancer who still have some cancer cells after initial treatment. The study aims to find the safest and most effective dose of Sarilumab (Phase 1) and then see how well the combination works to eliminate remaining cancer cells (Phase 2). Success in Phase 1 means finding a safe dose, and in Phase 2, it means seeing a reduction in cancer cells. The current status of this study is unclear, and it plans to enroll 65 participants.
- Study design
- This study has two phases: Phase 1 is a dose-finding study, and Phase 2 is a single-arm study comparing the treatment to historical results. It plans to enroll 65 participants.
- What's involved
- You would receive Sarilumab injections and take Capecitabine pills. Blood samples will be taken during treatment, and bone marrow samples are optional.
- Compensation
- Not stated in the trial record.
- Follow-up
- For Phase 1, safety is measured up to 9 weeks. For Phase 2, the change in cancer cells is measured from baseline up to 14 weeks.
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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)
Recruiting
PHASE1Ages 18–99InterventionalTreatmentUniversity of Southern CaliforniaInvestigator-initiated
~65 participants
Updated 2026-03-10 on ClinicalTrials.gov
What's tested:CapecitabineSarilumab 150mg or 200 mg plus CapecitabineSarilumab 150mg plus Capecitabine
At a glance
Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I: Maximum Tolerated Dose (MTD)
Measured over first treatment up to 9 weeks
+2 more outcomes measured
Conditions
Where it's being run
3 sites across 2 statesCalifornia2
Florida1
Study leadership
- Anastasia Martynova, MD · PRINCIPAL_INVESTIGATOR · University of Southern California
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
A. Written informed consent obtained from the subject and the ability for the subject to comply with all the study-related procedures.
B. Both males and females ≥ eighteen years of age
C. A clinical diagnosis of metastatic triple negative or hormone resistant, Her2/neu-negative breast cancer that has been confirmed histologically at one point during the course of the disease. TNBC is defined as ER/PR IHC positivity rate of \<10% and Her2Neu-negative (Phase I only)
D. A life expectancy of at least 6 months. (Phase I only)
E. Any previous cytotoxic chemotherapy must have been a minimum of 3 weeks prior to study drug administration. There is no limit on the number of prior therapies. For ER/PR-positive tumors, endocrine therapy must have been included in at least one of those prior regimens. Prior capecitabine is allowed only if not given in the treatment regimen immediately prior to the enrollment in this study. (Phase I only)
F. A diagnosis of TNBC confirmed histologically and defined as ER/PR IHC positivity rate of \<10% and Her2/neu-negative. (Phase II and Parallel Baseline Arm only)
G. A pathologic confirmation of stage I, or II, or III breast cancer with less than a complete pCR, defined as the absence of residual invasive cancer in resected breast specimen and sampled lymph nodes with residual noninvasive cancer or in situ disease allowed. (Phase II and Parallel Baseline Arm only)
H. Must not have received prior systemic treatment for breast cancer except for those included in the neoadjuvant regimen and the neoadjuvant regimen must not have included capecitabine nor sarilumab. (Phase II and Parallel Baseline Arm only)
I. An ECOG Performance Status ≤2.
J. Adequate organ function defined as:
K. Women of childbearing potential (WOCBP) must be using a highly effective method of contraception to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug to minimize the risk of pregnancy. Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
L. Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug.
Exclusion
A. Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 24 weeks after the last dose of study drug.
B. Females who are pregnant or breastfeeding.
C. History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
D. Hepatitis B infection except for prior vaccination. (Phase I and Phase II only).
E. Known history of tuberculosis injection. (Phase I and Phase II only).
F. A history of diverticulitis. (Phase I and Phase II only).
G. Use of live vaccines within 30 days prior to study treatment due to the risk of infection. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella (MMR), varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed. (Phase I and Phase II only)
H. History of other malignancy that in the primary oncologist's estimation has at the time of study participation a higher risk of recurrence or death than the study-related cancer.
I. Prisoners or subjects who are involuntarily incarcerated.
J. Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
K. Subjects demonstrating an inability to comply with the study and/or follow-up procedures.
What this trial measures
- Phase I: Maximum Tolerated Dose (MTD)first treatment up to 9 weeks
Establish MTD of sarilumab plus capecitabine in patients with metastatic TNBC and metastatic HER2/neu-negative and hormone resistant breast cancer
- Phase I: Dose-limiting toxicity (DLT)first treatment up to 9 weeks
Defined events that are possibly, probably, or definitely related to the study treatment:
- Phase II:To determine the percent of patients with positive CTCs and DTCs (if available) becoming negative CTCs and DTCs (if available) after treatmentbaseline up to 14 weeks
Bone marrow aspirates will be performed before treatment and at defined time points during treatment.