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.
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