OncoMatch/Clinical Trials/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)
Is NCT04333706 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Capecitabine and Sarilumab 150mg or 200 mg plus Capecitabine for breast.
Treatment: Capecitabine · Sarilumab 150mg or 200 mg plus Capecitabine · Sarilumab 150mg plus Capecitabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 IHC positivity rate <10% (<10%)
TNBC is defined as ER/PR IHC positivity rate of <10% and Her2Neu-negative
Required: PR (PGR) IHC positivity rate <10% (<10%)
TNBC is defined as ER/PR IHC positivity rate of <10% and Her2Neu-negative
Required: HER2 (ERBB2) wild-type
Her2/neu-negative
Disease stage
Required: Stage I, II, III
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)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: endocrine therapy
For ER/PR-positive tumors, endocrine therapy must have been included in at least one of those prior regimens.
Cannot have received: capecitabine (capecitabine)
Exception: allowed only if not given in the treatment regimen immediately prior to the enrollment in this study
Prior capecitabine is allowed only if not given in the treatment regimen immediately prior to the enrollment in this study.
Cannot have received: capecitabine (capecitabine)
Exception: neoadjuvant regimen must not have included capecitabine
the neoadjuvant regimen must not have included capecitabine nor sarilumab. (Phase II and Parallel Baseline Arm only)
Cannot have received: sarilumab (sarilumab)
Exception: neoadjuvant regimen must not have included sarilumab
the neoadjuvant regimen must not have included capecitabine nor sarilumab. (Phase II and Parallel Baseline Arm only)
Lab requirements
Blood counts
ANC > 1500/mcl (use of G-CSF is allowed); Platelets ≥ 100,000/mcl; Hemoglobin ≥ 9 (pRBC +/- ESA are allowed)
Kidney function
GFR ≥ 30 ml/min
Liver function
ALT ≤ 5 x ULN; AST ≤ 5 x ULN; Bilirubin ≤ 3 x ULN
Adequate organ function defined as: 1. Absolute neutrophil count (ANC) > 1500/mcl (use of G-CSF is allowed) 2. Platelets ≥ 100,000/mcl 3. Hemoglobin ≥ 9 (pRBC +/- ESA are allowed) 4. ALT ≤ 5 x ULN 5. AST ≤ 5 x ULN 6. Bilirubin ≤ 3 x ULN 7. GFR ≥ 30 ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Los Angeles General Medical Center · Los Angeles, California
- USC/Norris Comprehensive Cancer Center · Los Angeles, California
- UF Health · Gainesville, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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