Trial ID or NCT#

NCT03125902

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

A Phase III, Multicenter, Randomised, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-Pd-L1 Antibody) in Combination With Paclitaxel Compared With Placebo With Paclitaxel for Patients With Previously Untreated Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Melinda L. Telli, M.D.
Melinda L. Telli, M.D.
Medical oncologist, Breast specialist
Associate Professor of Medicine (Oncology)
Douglas W. Blayney
Douglas W. Blayney
Medical oncologist, Breast specialist
Professor of Medicine (Oncology)
George W. Sledge Jr., M.D.
George W. Sledge Jr., M.D.
Medical oncologist, Breast specialist
Professor of Medicine (Oncology)

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CONTACT

CCTO
(650) 498-7061