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
Public ClinicalTrials.gov record NCT02322814. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multistage, Phase II Study Evaluating the Safety and Efficacy of Cobimetinib Plus Paclitaxel, Cobimetinib Plus Atezolizumab Plus Paclitaxel, or Cobimetinib Plus Atezolizumab Plus Nab-Paclitaxel as First-Line Treatment for Patients With Metastatic Triple-Negative Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02322814
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 169 participants
Conditions and interventions
Conditions
Interventions
- Cobimetinib Drug
- Paclitaxel Drug
- Placebo Drug
- Atezolizumab Drug
- Nab-Paclitaxel Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 11, 2015
- Primary completion
- Aug 9, 2018
- Completion
- Sep 16, 2021
- Last update posted
- Apr 12, 2023
2015 – 2021
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cancer Specialists of North Florida | Jacksonville | Florida | 32256-6932 | — |
| Mercy Hospital, a Campus of Plantation General Hospital | Miami | Florida | 33133 | — |
| Florida Hospital Cancer Inst | Orlando | Florida | 32804 | — |
| Florida Cancer Research Institute | Plantation | Florida | 33324 | — |
| Cancer Treatment Centers of America | Newnan | Georgia | 30265 | — |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | — |
| Montefiore Einstein Cancer Center | The Bronx | New York | 10461 | — |
| Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | — |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 42 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02322814, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 12, 2023 · Synced Sep 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02322814 live on ClinicalTrials.gov.