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NCT02425891 · ClinicalTrials.gov registry record · Phase 3
A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)
A Phase 3 study of Triple Negative Breast Cancer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 902
- Enrollment target
- 20
- Study locations
NCT02425891: Completed Phase 3 study of Triple Negative Breast Cancer, sponsored by Hoffmann-La Roche.
NCT02425891 is a Phase 3 study of Triple Negative Breast Cancer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 902 participants, above the 239-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (277% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02425891, a Phase 3 study of Triple Negative Breast Cancer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 902 participants
- Enrollment target
- 20
- Study locations
Study Summary
This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.
Primary Outcome
PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Nab-Paclitaxel
- DRUG Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Study Locations (20)
California
- Kaiser Permanente of Northern California - Oakland
- Emad Ibrahim, Md, Inc - Redlands
- Univ of Calif, San Francisco; Breast Cancer Center - San Francisco
- Kaiser Permanente - San Marcos - San Marcos
- Cancer Research Collaboration, Inc. - Santa Ana
- Stanford Univ School of Med; Oncology - Stanford
Florida
- Florida Cancer Specialists - SCRI; Pharmacy - Fort Myers
- Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy) - Jacksonville
- The Mount Siani Comprehensive Cancer Center - Miami Beach
- Florida Cancer Research Institute - Plantation
- Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) - St. Petersburg
Connecticut
- Yale Cancer Center; Medical Oncology - New Haven
- Norwalk Hospital - Norwalk
- Stamford Hospital; BCC, MOHR - Stamford
Alabama
- University of Alabama at Birmingham - Birmingham
Arkansas
- Highlands Oncology Group - Springdale
Colorado
- Kaiser Permanente Of Colorado - Aurora
District of Columbia
- MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center) - Washington D.C.
Georgia
- Northwest Georgia Oncology Centers PC - Marietta - Marietta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 902 participants |
| Start Date | 2015-06-23 |
| Est. Completion | 2021-08-31 |
| Phase | Phase 3 |
What the finished NCT02425891 record still lists
NCT02425891 is an interventional study that assigns participants to a tested intervention. The registered 902 participants enrollment target is mid-sized for trials with a published cap, above the 239-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (277% higher).
The record links to 1 condition, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02425891 names 20 study sites across 9 states, led by California, Florida, Connecticut.
Frequently Asked Questions
What is clinical trial NCT02425891 about?
NCT02425891 is a clinical study titled "A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)". This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cance...
What is the current status of trial NCT02425891?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 902 participants. The study started on 2015-06-23. Estimated completion is 2021-08-31.
What conditions does trial NCT02425891 study?
This clinical trial studies the following conditions: Triple Negative Breast Cancer.
What interventions are being tested in trial NCT02425891?
The interventions under investigation include: Placebo (DRUG), Nab-Paclitaxel (DRUG), Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody (DRUG).
Who is sponsoring clinical trial NCT02425891?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02425891 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Triple Negative Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02425891's enrollment target sits among peer trials
902 7th of 118 higher than 112 of 118 other Triple Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Triple Negative Breast 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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ACTIVE NOT RECRUITING · Phase 3
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