A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple Negative Breast Cancer (IMpassion130)

Official Title

A Phase III, Multicentre, Randomized Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Nab Paclitaxel Compared With Placebo With Nab Paclitaxel for Patients With Previously Untreated Metastatic Triple Negative Breast Cancer

Summary:

This study is being conducted to determine the efficacy and safety in using Atezolizumab in combination with nab-paclitaxel in treating participants with metastatic breast cancer. The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with metastatic breast cancer, and preliminary data shows the use of Atezolizumab is safe to use in combination with chemotherapy.

Trial Description

Primary Outcome:

  • Progression Free Survival (PFS)
  • Overall Survival (OS)
Secondary Outcome:
  • Objective Response Rate (ORR)
  • Duration of Objective Response (DOR)
  • Time to Deterioration (TTD) in Global Health Status/Health-Related Quality of Life (HRQoL)
  • Percentage of Participants with Adverse Events (AEs), including Serious AEs and Non-Serious AEs
  • Percentage of Participants with Clinically Significant Changes in Safety Measurements, Including Vital Signs, Physical Findings and Clinical Laboratory Results
  • Percentage of Anti-Therapeutic Antibody (ATA) Response 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