NCT02091960

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• HER2 Amplified
• Advanced Breast Cancer
• Human Epidermal Growth Factor Receptor 2 (HER2)

Interventions

Type	Name	Description
DRUG	Enzalutamide	Capsules for oral administration
DRUG	Trastuzumab	Intravenous infusion (IV) or subcutaneous injection if it is standard of care within a country

Timeline

• Start date: 2014-09-05
• Primary completion: 2017-02-28
• Completion: 2024-01-30
• First posted: 2014-03-19
• Last updated: 2025-04-04
• Results posted: 2018-05-16

Locations

39 sites across 6 countries: United States, Belgium, Canada, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study