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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 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 653 participants.

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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.

Interventions

  • DRUG Paclitaxel
  • DRUG Atezolizumab Placebo
  • DRUG Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody

Trial Details

FieldValue
Enrollment Target 653 participants
Start Date 2017-08-25
Est. Completion 2023-01-17
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT03125902

The ClinicalTrials.gov registry entry for NCT03125902 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 653 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 3 interventions - of which Paclitaxel is the first listed.

NCT03125902 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.