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Clinical trial

A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer (IMpassion031)

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Last updated:23rd Jul 2017
Identifier: NCT03197935

This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) and nab-paclitaxel followed by doxorubicin and cyclophosphamide (nab-pac-AC), or placebo and nab-pac−AC in participants eligible for surgery with initial clinically assessed triple-negative breast cancer (TNBC).

Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Neoadjuvant Anthracycline/Nab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invasive Triple-Negative Breast Cancer
Actual Study Start Date: July 24, 2017
Estimated Primary Completion Date: September 30, 2020
Estimated Study Completion Date: January 31, 2023

- Experimental:
Atezolizumab and Chemotherapy
- Placebo Comparator: Placebo and Chemotherapy

Category Value
Date last updated at source 2019-07-18
Study type(s) Interventional
Expected enrolment 324
Study start date 2017-07-24
Estimated primary completion date 2020-09-30

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