# 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 S

Source: https://onco.cc/trials/nct04333706/  
OnCo record `nct04333706` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of capecitabine in triple-negative breast cancer, run by University of Southern California, now recruiting.

## Summary

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 a phase 1/2, interventional study registered as NCT04333706 by University of Southern California, with a registry enrolment figure of 65 participants, started 2020-09-26 and due to reach its primary completion in 2026-11-03. Interventions recorded: Capecitabine; Sarilumab 150mg or 200 mg plus Capecitabine; Sarilumab 150mg plus Capecitabine. Conditions listed: Breast; Metastatic; Triple Negative; Cancer; Disseminated Tumor Cell. Triple-negative eligibility wording from the registry: "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". Sites: United States. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-24
- Also known as: EMPOWER
- Tags: ctgov-ingest; tnbc-deep-dive
- Registry id: NCT04333706
- Phase: 1/2
- Setting: 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)
- Sponsor: University of Southern California
- Enrolled: 65

## Sources

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

## Connected records

- cancers: [Early triple-negative breast cancer](https://onco.cc/cancers/tnbc-early/), [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/)
- terms: [Triple-negative breast cancer trials open today (registry snapshot and UK sites)](https://onco.cc/terms/tnbc-trials-open-today/)

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