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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: Recruiting Phase 1 study of Cancer and Metastatic, sponsored by University of Southern California.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Establish MTD of sarilumab plus capecitabine in patients with metastatic TNBC and metastatic HER2/neu-negative and hormone resistant breast cancer
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 |
What NCT04333706 shows while recruiting
NCT04333706 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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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Where NCT04333706's enrollment target sits among peer trials
65 386th of 615 higher than 229 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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