# 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)

> **NCT04333706** · PHASE1,PHASE2 · RECRUITING · sponsor: **University of Southern California** · enrollment: 65 (estimated)

## Conditions studied

- Breast
- Metastatic
- Triple Negative
- Cancer
- Disseminated Tumor Cell

## Interventions

- **DRUG:** Capecitabine
- **COMBINATION_PRODUCT:** Sarilumab 150mg or 200 mg plus Capecitabine
- **COMBINATION_PRODUCT:** Sarilumab 150mg plus Capecitabine

## Key facts

- **NCT ID:** NCT04333706
- **Lead sponsor:** University of Southern California
- **Sponsor class:** OTHER
- **Phase:** PHASE1,PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2020-09-26
- **Primary completion:** 2026-11-03
- **Final completion:** 2027-05-03
- **Target enrollment:** 65 (ESTIMATED)
- **Last updated:** 2026-03-10

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04333706

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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)". Retrieved via AI Analytics 2026-07-22 from https://api.ai-analytics.org/clinical/NCT04333706. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*