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

Official Title

A Phase III, Multicentre, 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

Summary:

This Phase 3, multicentre, 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.

Trial Description

Primary Outcome:

• Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in the Subpopulation with Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status
• Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population

• Overall Survival (OS) in the PD-L1-Positive Subpopulation
• Overall Survival (OS) in the ITT Population
• Percentage of Participants Who are Alive at 12 and 18 Months
• Time to deterioration (TTD) in Global Health Status/ Health Related Quality of Life (HRQoL)
• Percentage of Participants Who are Alive Without Progression Event at Month 12 Assessed Using RECIST v1.1
• Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Subpopulation
• Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the ITT Population
• Duration of Objective Response (DOR) Assessed Using RECIST v1.1
• Percentage of Participants With Clinical Benefit Assessed Using RECIST v1.1
• Minimum Observed Serum Concentration (Cmin) of Atezolizumab
• Maximum Observed Serum Concentration (Cmax) of Atezolizumab
• Minimum Observed Plasma Concentration (Cmin) of Paclitaxel
• Maximum Observed Plasma Concentration (Cmax) of Paclitaxel
• Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
• Percentage of Participants With Drug Antibodies (ADAs)
• Change From Baseline in PD-L1 Expression by Immunohistochemistry at Approximately 45 Months
• Confirmed Objective Response Rate (C-ORR)
• Duration of Confirmed Response (C-DoR)

View this trial on ClinicalTrials.gov