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

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

Summary:

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).

Trial Description

Primary Outcome:

  • Percentage of Participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System
  • Percentage of Participants with pCR in Subpopulation with PD-L1-Positive Tumour Status (tumour-infiltrating immune cell [IC] 1/2/3) Using AJCC Staging System
Secondary Outcome:
  • Event-Free Survival (EFS) in All Participants
  • Event-Free Survival (EFS) in Subpopulation with PD-L1-Postive Tumour Status
  • Disease-Free Survival (DFS) in All Participants Who Undergo Surgery
  • Disease-Free Survival (DFS) in Subpopulation of Participants with PD-L1-Positive Tumour Status Who Undergo Surgery
  • Overall survival (OS) in All Participants
  • Overall survival (OS) in Subpopulation with PD-L1-Positive Tumour Status
  • Changes From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score
  • Percentage of Participants with Adverse Events (AEs)
  • Serum Concentration of Atezolizumab
  • Percentage of Participants with Anti-Drug Antibodies (ADAs) to Atezolizumab

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society