A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Subjects With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer

Official Title

A Phase 2, Multicentre, Open-label Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Subjects With HER2+ AR+ Metastatic or Locally Advanced Breast Cancer

Summary:

The purpose of this study is to evaluate the efficacy of enzalutamide with trastuzumab in subjects with HER2+ AR+ metastatic or locally advanced breast cancer.

Trial Description

Primary Outcome:

  • Clinical benefit rate (CBR)
Secondary Outcome:
  • Overall response rate (CR+PR) according to RECIST 1.1 criteria
  • Best overall response rate according to RECIST 1.1 criteria
  • Progression free survival
  • Time to progression
  • Duration of response
  • Time to response
  • Safety assessed by physical examinations, vital signs, laboratory assessments, electrocardiograms, left ventricular ejection fraction (LVEF) by echocardiogram or multi-gated acquisition scan (MUGA), and evaluation of adverse events

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