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)
Public ClinicalTrials.gov record NCT04333706. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04333706
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 65 participants
Conditions and interventions
Conditions
Interventions
- Capecitabine Drug
- Sarilumab 150mg or 200 mg plus Capecitabine Combination Product
- Sarilumab 150mg plus Capecitabine Combination Product
Drug · Combination Product
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 25, 2020
- Primary completion
- Nov 2, 2026
- Completion
- May 2, 2027
- Last update posted
- Mar 9, 2026
2020 – 2027
United States locations
- U.S. sites
- 3
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Los Angeles General Medical Center | Los Angeles | California | 90033 | Recruiting |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Recruiting |
| UF Health | Gainesville | Florida | 32610 | Active, not recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04333706, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 9, 2026 · Synced Sep 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04333706 live on ClinicalTrials.gov.