NCT04333706 · University of Southern California
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)
(EMPOWER)
What this study 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.
View original scientific description
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.
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.
Primary outcome measures
Phase I: Maximum Tolerated Dose (MTD)
Time frame: 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)
Time frame: 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 treatment
Time frame: baseline up to 14 weeks
Bone marrow aspirates will be performed before treatment and at defined time points during treatment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 confi
Where
- Los Angeles, California
- Gainesville, Florida
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 10, 2026 · Source of record for eligibility and locations