RecruitingPhase 2NCT06365788

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


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

53 participants

Start Date

Apr 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining two drugs — bicalutamide (a hormone-blocking drug) and abemaciclib (a cell cycle inhibitor) — can treat a specific type of breast cancer called androgen receptor-positive triple-negative breast cancer that cannot be surgically removed or has spread. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with triple-negative breast cancer that tests positive for androgen receptors - Your cancer is inoperable or metastatic - You have received prior treatment and your cancer has progressed **You may NOT be eligible if...** - You have received prior treatment with a CDK4/6 inhibitor or androgen receptor-targeting drug - You have significant heart problems or uncontrolled other cancers - You are pregnant or breastfeeding - You have certain serious infections or autoimmune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbemaciclib

150 mg tablet orally twice daily

DRUGBicalutamide

150 mg tablet orally once daily


Locations(6)

ZAS Augustinus

Antwerp, Belgium

Antwerp University Hospital

Antwerp, Belgium

University Hospital Brussels

Brussels, Belgium

Ghent University Hospital

Ghent, Belgium

Jessa Ziekenhuis

Hasselt, Belgium

University Hospitals Leuven

Leuven, Belgium

View Full Details on ClinicalTrials.gov

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NCT06365788


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