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NCT02322814 · ClinicalTrials.gov registry record · Phase 2
A Study of Cobimetinib Plus Paclitaxel, Cobimetinib Plus Atezolizumab Plus Paclitaxel, or Cobimetinib Plus Atezolizumab Plus Nab-Paclitaxel as Initial Treatment for Participants With Triple-Negative Breast Cancer That Has Spread
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 2
- Development phase
- 169
- Enrollment target
NCT02322814 is a Phase 2 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 169 participants.
The verdict
NCT02322814, a Phase 2 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 169 participants
- Enrollment target
Study Summary
This three-cohort, multi-stage, randomized, Phase II, multicenter trial will evaluate the safety and tolerability and estimate the efficacy of cobimetinib plus paclitaxel versus placebo plus paclitaxel in Cohort I, of cobimetinib plus atezolizumab plus paclitaxel in Cohort II, and of cobimetinib plus atezolizumab plus nab-paclitaxel in Cohort III in participants with metastatic or locally advanced, triple-negative adenocarcinoma of the breast who have not received prior systemic therapy for metastatic breast cancer (MBC). Participants may continue on study treatment until the development of progressive disease (PD) or the loss of clinical benefit, unacceptable toxicity, and/or consent withdrawal. The Cohort I target sample size is 12 participants for the safety run-in stage and approximately 90 participants in the expansion stage. Each of Cohorts II and III will consist of a safety run-in stage of approximately 15 participants followed by an expansion stage of approximately 15 participants.
Interventions
- DRUG Placebo
- DRUG Atezolizumab
- DRUG Paclitaxel
- DRUG Nab-Paclitaxel
- DRUG Cobimetinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2015-03-12 |
| Est. Completion | 2021-09-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02322814
The ClinicalTrials.gov registry entry for NCT02322814 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 169 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02322814 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02322814 about?
NCT02322814 is a clinical study titled "A Study of Cobimetinib Plus Paclitaxel, Cobimetinib Plus Atezolizumab Plus Paclitaxel, or Cobimetinib Plus Atezolizumab Plus Nab-Paclitaxel as Initial Treatment for Participants With Triple-Negative Breast Cancer That Has Spread". This three-cohort, multi-stage, randomized, Phase II, multicenter trial will evaluate the safety and tolerability and estimate the efficacy of cobimetinib plus paclitaxel versus placebo plus paclitaxel in Cohort I, of cobimetinib plus atezolizumab plus paclitaxel in Cohort II, and of cobimetinib plu...
What is the current status of trial NCT02322814?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 169 participants. The study started on 2015-03-12. Estimated completion is 2021-09-17.
What interventions are being tested in trial NCT02322814?
The interventions under investigation include: Placebo (DRUG), Atezolizumab (DRUG), Paclitaxel (DRUG), Nab-Paclitaxel (DRUG), Cobimetinib (DRUG).
Who is sponsoring clinical trial NCT02322814?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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