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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: Clinical Trial Phase 2 study, sponsored by Hoffmann-La Roche.
NCT02322814 is a Phase 2 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 169 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS was defined as the time from randomization to the first occurrence of disease progression or relapse, as determined by the investigator, using RECIST v1.1. As per RECIST v1.1, progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appeara
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 |
Why NCT02322814 stopped before completion
NCT02322814 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT02322814 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02322814's enrollment target sits among peer trials
169 403rd of 2000 higher than 1,598 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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