Last updated on November 2019

A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)

Brief description of study

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.

Clinical Study Identifier: NCT03125902

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Stanford Cancer Center

Stanford, CA United States
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Northwestern University

Chicago, IL United States
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The Valley Hospital

Paramus, NJ United States
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Magee-Woman's Hospital

Pittsburgh, PA United States
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CHD Les Oudairies

La Roche Sur Yon, France
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Manchester, United Kingdom
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Mount Vernon Cancer Centre

Northwood, United Kingdom
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Hanoi, Vietnam
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Edinburgh, United Kingdom
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Florida Cancer Specialist, North Region

Saint Petersburg, FL United States
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Kansas City, MO United States
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Samsung Medical Center

Seoul, Korea, Republic of
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Ulsan, Korea, Republic of
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Banská Bystrica, Slovakia
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