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NCT03125902 · ClinicalTrials.gov registry record · Phase 3
A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 653
- Enrollment target
NCT03125902: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT03125902 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 653 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03125902, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 653 participants
- Enrollment target
Study Summary
This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 \[PD-L1\] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time.
Primary Outcome
PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
Interventions
- DRUG Paclitaxel
- DRUG Atezolizumab Placebo
- DRUG Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 653 participants |
| Start Date | 2017-08-25 |
| Est. Completion | 2023-01-17 |
| Phase | Phase 3 |
What the finished NCT03125902 record still lists
NCT03125902 is an interventional study that assigns participants to a tested intervention. The registered 653 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 3 interventions - of which Paclitaxel is the first listed.
NCT03125902 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03125902 about?
NCT03125902 is a clinical study titled "A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)". This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 \[PD-L1\] antibody) administered in combination with paclitaxel compared with placebo in combination with paclit...
What is the current status of trial NCT03125902?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 653 participants. The study started on 2017-08-25. Estimated completion is 2023-01-17.
What interventions are being tested in trial NCT03125902?
The interventions under investigation include: Paclitaxel (DRUG), Atezolizumab Placebo (DRUG), Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody (DRUG).
Who is sponsoring clinical trial NCT03125902?
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 NCT03125902's enrollment target sits among peer trials
653 571st of 2000 higher than 1,430 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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