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NCT04333706 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study of Cancer and Metastatic, sponsored by University of Southern California.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
- 3
- Study locations
NCT04333706 is a Phase 1 study of Cancer and Metastatic that is actively recruiting participants, run by University of Southern California. The registered enrollment target is 65 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT04333706, a Phase 1 study of Cancer and Metastatic, is actively recruiting participants, sponsored by University of Southern California.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Capecitabine
- COMBINATION_PRODUCT Sarilumab 150mg or 200 mg plus Capecitabine
- COMBINATION_PRODUCT Sarilumab 150mg plus Capecitabine
Study Locations (3)
California
- Los Angeles General Medical Center - Los Angeles
- USC/Norris Comprehensive Cancer Center - Los Angeles
Florida
- UF Health - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2020-09-26 |
| Est. Completion | 2027-05-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04333706
The ClinicalTrials.gov registry entry for NCT04333706 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (98% lower). The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Cancer appearing as the primary indexed condition, and to 3 interventions - of which Capecitabine is the first listed.
NCT04333706 reports 3 study locations spanning 2 distinct geographic areas - top geographies include California, Florida.
Frequently Asked Questions
What is clinical trial NCT04333706 about?
NCT04333706 is a clinical study titled "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)". 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 ...
What is the current status of trial NCT04333706?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2020-09-26. Estimated completion is 2027-05-03.
What conditions does trial NCT04333706 study?
This clinical trial studies the following conditions: Cancer, Metastatic, Breast, Triple Negative, Disseminated Tumor Cell.
What interventions are being tested in trial NCT04333706?
The interventions under investigation include: Capecitabine (DRUG), Sarilumab 150mg or 200 mg plus Capecitabine (COMBINATION_PRODUCT), Sarilumab 150mg plus Capecitabine (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04333706?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04333706 being conducted?
This trial has 3 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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