A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy

Official Title

A Randomized, Multicentre, Double-Blind, Placebo-Controlled Phase II Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab and Taxane Based Therapy

Summary:

This Phase II, double-blind, randomized, placebo-controlled multicentre study will investigate the efficacy and safety of trastuzumab emtansine in combination with atezolizumab or atezolizumab-placebo in participants with HER2-positive locally advanced or metastatic BC who have received prior trastuzumab and taxane based therapy, either alone or in combination, and/or who have progressed within 6 months after completing adjuvant therapy.

Trial Description

Primary Outcome:

  • Progression-Free Survival (PFS) as Determined by Investigator's Tumour Assessment Using Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 (v1.1)
  • Percentage of Participants with Adverse Events
Secondary Outcome:
  • Overall Survival (OS)
  • Percentage of Participants With Objective Response (OR) as Determined by Investigator's Tumour Assessment Using RECIST v1.1
  • Duration of OR as Determined by Investigator's Tumour Assessment Using RECIST v1.1
  • Maximum Serum Concentration (Cmax) of Trastuzumab Emtansine
  • Serum Concentration of Total Trastuzumab
  • Maximum Plasma Concentration of Deacetyl Mercapto 1-Oxopropyl Maytansine
  • Cmax of Atezolizumab
  • Percentage of Participants With Anti-therapeutic Antibodies (ATAs) to Atezolizumab
  • Percentage of Participants With ATAs to Trastuzumab Emtansine

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