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 Who Have Received Prior Trastuzumab and Taxane Based Therapy

Official Title

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 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 breast cancer 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) v1.1
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
  • Percentage of Participants With Adverse Events
  • Maximum Serum Concentration of Trastuzumab Emtansine
  • Serum Concentration of Total Trastuzumab
  • Maximum Plasma Concentration of Deacetyl mercapto 1-oxopropyl maytansine (DM1)
  • Maximum Serum Concentration of Atezolizumab
  • Percentage of Participants With Anti-therapeutic Antibodies (ATA) to Atezolizumab
  • Percentage of Participants With ATA 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