RecruitingPhase 1Phase 2NCT04333706

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

Enrollment

65 participants

Start Date

Sep 26, 2020

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Metastatic Triple Negative Disseminated Tumor Cell

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study has two parts: the first tests a new drug combination (sarilumab + capecitabine) in people with metastatic HER2-negative triple-negative breast cancer to find the right dose; the second part tests this combination in people with early-stage triple-negative breast cancer who had cancer remaining after standard pre-surgery chemotherapy (high-risk residual disease). Sarilumab is an anti-inflammatory drug being repurposed to potentially enhance chemotherapy. **You may be eligible if...** - You are 18 years or older - For Phase 1: You have metastatic triple-negative or hormone-resistant, HER2-negative breast cancer - For Phase 2: You have stage I–III triple-negative breast cancer with cancer still present after pre-surgery chemotherapy - Your overall health allows for participation - You have a life expectancy of at least 6 months (Phase 1) **You may NOT be eligible if...** - You have HER2-positive breast cancer - You recently received capecitabine as your most recent treatment (Phase 1) - You have already received systemic treatment for your breast cancer (Phase 2) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCapecitabine

Capecitabine 1000 mg BID

COMBINATION_PRODUCTSarilumab 150mg or 200 mg plus Capecitabine

Sarilumab 150mg or 200 mg plus Capecitabine 1000 mg BID

COMBINATION_PRODUCTSarilumab 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.