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NCT03202316 · ClinicalTrials.gov registry record · Phase 2
Atezolizumab, Cobimetinib, and Eribulin in Treating Patients With Chemotherapy Resistant Metastatic Inflammatory Breast Cancer
A Phase 2 study of Recurrent Breast Inflammatory Carcinoma and Stage IV Breast Inflammatory Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT03202316: Active Phase 2 study of Recurrent Breast Inflammatory Carcinoma and Stage IV Breast Inflammatory Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT03202316 is a Phase 2 study of Recurrent Breast Inflammatory Carcinoma and Stage IV Breast Inflammatory Carcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03202316, a Phase 2 study of Recurrent Breast Inflammatory Carcinoma and Stage IV Breast Inflammatory Carcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well atezolizumab, cobimetinib, and eribulin work in treating patients with inflammatory breast cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as eribulin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving atezolizumab, cobimetinib, and eribulin may work better in treating patients with inflammatory breast cancer.
Primary Outcome
Calculated per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. ORR is defined as the rate of patients who achieved partial response or complete response as the best response. All tumor response will be evaluated by RECIST 1.1. The ORR will be estimated along with 95% confidence intervals. Logistic regression model will be used to assess other variables' effect on the best ORR.
Conditions Studied
Interventions
- DRUG Atezolizumab
- OTHER Laboratory Biomarker Analysis
- DRUG Eribulin
- DRUG Cobimetinib
- OTHER Pharmacological Study
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2017-08-11 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What the registry record for NCT03202316 still lists
NCT03202316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).
The record links to 2 conditions, with Recurrent Breast Inflammatory Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Atezolizumab is the first listed.
NCT03202316 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03202316 about?
NCT03202316 is a clinical study titled "Atezolizumab, Cobimetinib, and Eribulin in Treating Patients With Chemotherapy Resistant Metastatic Inflammatory Breast Cancer". This phase II trial studies how well atezolizumab, cobimetinib, and eribulin work in treating patients with inflammatory breast cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack th...
What is the current status of trial NCT03202316?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2017-08-11. Estimated completion is 2027-12-31.
What conditions does trial NCT03202316 study?
This clinical trial studies the following conditions: Recurrent Breast Inflammatory Carcinoma, Stage IV Breast Inflammatory Carcinoma.
What interventions are being tested in trial NCT03202316?
The interventions under investigation include: Atezolizumab (DRUG), Laboratory Biomarker Analysis (OTHER), Eribulin (DRUG), Cobimetinib (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT03202316?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03202316 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03202316's enrollment target sits among peer trials
37 1484th of 2000 higher than 505 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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