NCT06365788

Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer

A Multicenter Single Arm Phase II Study With Bicalutamide in Combination With Abemaciclib in 4 Cohorts of Locoregionally Advanced Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study has as goal to evaluate the use of abemaciclib and bicalutamide in androgen receptor positive metastatic triple negative breast cancer.

Detailed description

This study is a phase II single arm clinical trial. Phase II clinical trials test the safety and effectiveness of an intervention to learn whether the intervention works in treating a specific disease. In this study, the investigators will include patients with locally advanced unresectable or metastatic androgen receptor positive triple negative breast cancer. The participants need to be progressive after at least 1 prior cytostatic regimen in advanced setting. The participants will be treated with bicalutamide and abemaciclib. Bicalutamide works against the androgen receptor and abemaciclib stops the cell cycle. The investigators will look into if this combination can help patients with androgen receptor positive triple negative breast cancer. The investigators will also look into if this is a safe combination.

Conditions

• Triple Negative Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Abemaciclib	150 mg tablet orally twice daily
DRUG	Bicalutamide	150 mg tablet orally once daily

Timeline

• Start date: 2024-04-08
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2024-04-15
• Last updated: 2026-04-01

Locations

6 sites across 1 country: Belgium

Regulatory

• FDA-regulated drug study