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)

Recruiting Phase 1 Phase 2 Interventional Study
Breast Metastatic Triple Negative Cancer Disseminated Tumor Cell
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 99
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
65 (estimated)
Sponsor
University of Southern California · Other
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About This Trial
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 tho…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * A. Written informed consent obtained from the subject and the ability for the subject to comply with all the study-related procedures. * B. Both males and females ≥ eighteen years of age * C. A clinical diagnosis of metastatic triple negative or hormone resistant, Her2/neu-neg…
Contacts

Kimberly Arieli, RN

323-865-3935

Kimberly.Arieli@med.usc.edu

CONTACT