NCT03383679

Study on Androgen Receptor and Triple Negative Breast Cancer

A Randomized Phase 2 Study in Patients With Triple-negative Androgen Receptor Positive Locally Recurrent (Unresectable) or Metastatic Breast Cancer Treated With Darolutamide or Capecitabine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter uncontrolled, open-label, prospective, non-comparative randomized, phase II study. Patients will be randomized between darolutamide in Arm n°1 (two-stage Simon's design) and capecitabine in Arm n°2 with two patients randomized in Arm n°1 for one patient randomized in Arm n°2. The trial population is composed of women over 18 years old with triple-negative and androgen receptor positive, locally recurrent (unresectable) or metastatic breast cancer.

Conditions

• Breast Cancer Female
• Triple Negative and Androgen Receptor Positive

Interventions

Type	Name	Description
DRUG	Darolutamide	treatment with darolutamide
DRUG	Capecitabine	treatment with capecitabine

Timeline

• Start date: 2018-03-14
• Primary completion: 2021-11-30
• Completion: 2022-07-20
• First posted: 2017-12-26
• Last updated: 2022-11-21

Locations

1 site across 1 country: France