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 multicentre, randomized, double-blind study will evaluate the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.

Trial Description

Primary Outcome:

  • Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 (v1.1) in all Randomized Participants
  • PFS According to RECIST v1.1 in Participants with Detectable Programmed Death-Ligand 1 (PD-L1)
  • Overall Survival (OS) in all Randomized Participants
  • OS in Participants with Detectable PD-L1
Secondary Outcome:
  • Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in all Randomized Participants
  • Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants with Detectable PD-L1
  • Duration of Response (DOR) According to RECIST v1.1 in all Randomized Participants
  • DOR Acccording to RECIST v1.1 in Participants with Detectable PD-L1
  • Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in all Randomized Participants
  • TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants with Detectable PD-L1
  • Percentage of Participants with Adverse Events (AEs) or Serious AEs (SAEs)
  • Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
  • Maximum Serum Concentration (Cmax) for Atezolizumab
  • Minimum Serum Concentration (Cmin) for Atezolizumab
  • Plasma Concentrations of Total Paclitaxel

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