Clinical Trial: Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase 2, Single Arm, Open Label, Multicenter Study of the Clinical Activity and Safety of Enzalutamide in Patients With Advanced, Androgen Receptor Positive, Triple Nega

Brief Summary: The purpose of this study is to determine if enzalutamide is safe and effective in the treatment of patients with advanced breast cancer that express the androgen receptor but do not express the estrogen or progesterone receptor and are not Her2 amplified.

Detailed Summary:
Sponsor: Medivation, Inc.

Current Primary Outcome: Clinical Benefit Rate [ Time Frame: ≥ 16 weeks ]

To determine clinical benefit rate, defined as the proportion of evaluable patients with androgen receptor positive (AR+), triple negative breast cancer (TNBC) with a best response of complete response (CR), partial response (PR), or stable disease (SD) ≥ 16 weeks.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical Benefit Rate [ Time Frame: ≥ 24 weeks ]
    To determine clinical benefit rate, defined as the proportion of evaluable patients with a best response of Complete Response, Partial Response, or Stable Disease ≥ 24 weeks;
  • Best Objective Response Rate [ Time Frame: ≥ 16 weeks ]
  • Duration of Response [ Time Frame: ≥ 16 weeks ]
  • Time to Response [ Time Frame: ≥ 16 weeks ]
  • Progression Free Survival (PFS) [ Time Frame: ≥ 16 weeks ]
  • Pharmacokinetics - Ctrough (predose plasma concentration) [ Time Frame: ≥ 16 weeks ]
    To assess the pharmacokinetics (PK) of enzalutamide and its active metabolite N desmethyl enzalutamide


Original Secondary Outcome:

  • Clinical Benefit Rate [ Time Frame: ≥ 24 weeks ]
    To determine clinical benefit rate, defined as the proportion of evaluable patients with a best response of Complete Response, Partial Response, or Stable Disease ≥ 24 weeks;
  • Best Objective Response Rate [ Time Frame: ≥ 16 weeks ]
  • Duration of Response [ Time Frame: ≥ 16 weeks ]
  • Time to Response [ Time Frame: ≥ 16 weeks ]
  • Progression Free Survival (PFS) [ Time Frame: ≥ 16 weeks ]
  • Pharmacokinetics - Ctrough [ Time Frame: ≥ 16 weeks ]
    To assess the pharmacokinetics (PK) of enzalutamide and its active metabolite N desmethyl enzalutamide


Information By: Medivation, Inc.

Dates:
Date Received: June 26, 2013
Date Started: June 2013
Date Completion: June 2017
Last Updated: December 20, 2016
Last Verified: December 2016