A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer

Official Title

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer

Summary:

This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab compared with placebo when given in combination with neoadjuvant dose-dense anthracycline (doxorubicin) + cyclophosphamide followed by paclitaxel + trastuzumab + pertuzumab (ddAC-PacHP) in patients with early HER2-positive breast cancer (T2-4, N1-3, M0).

Trial Description

Primary Outcome:

• Percentage of Participants with Pathological Complete Response (pCR) in the PD-L1-Positive Population (IC 1/2/3)
• pCR in the ITT Population

• Percentage of Participants with pCR Based on Hormone Receptor Status
• Percentage of Participants with pCR in the PD-L1-Negative Population
• Event-Free Survival (EFS)
• Disease-Free Survival (DFS)
• Overall Survival (OS)
• Mean Changes From Baseline in Function (Role, Physical)
• Mean Changes From Baseline in Global Health Status
• Percentage of Participants With Adverse Events
• Maximum Serum Concentration (Cmax) of Atezolizumab
• Minimum Serum Concentration (Cmin) of Atezolizumab
• Trough Concentration (Ctrough) for Pertuzumab and Trastuzumab in Serum
• Maximum Serum Concentration (Cmax) of Trastuzumab Emtansine in Serum
• Minimum Serum Concentration (Cmin) of Trastuzumab Emtansine in Serum
• Percentage of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs) to Atezolizumab
• Percentage of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs) to Trastuzumab
• Percentage of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs) to Pertuzumab
• Percentage of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs) to Trastuzumab Emtansine
• Percentage of Particpants with pCR Based on PIK3CA Mutation Status
• EFS Based on PIK3CA Mutation Status
• DFS Based on PIK3CA Mutation Status
• OS Based on PIK3CA Mutation Status

View this trial on ClinicalTrials.gov