Phase IBII Study of Abemaciclib with Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer

What this Trial Is About

Researchers are evaluating the combination of abemaciclib and bicalutamide in patients with androgen receptor-positive, HER2-negative metastatic breast cancer. This open-label, multicenter Phase IBII study aims to find the safe and recommended dose of abemaciclib when given with bicalutamide, and to assess how well this treatment works. The study also looks at safety, tolerability, and progression-free survival in patients who often have already received prior endocrine therapies. Participants will receive abemaciclib orally twice daily with dose adjustments based on tolerance, starting at 100 mg and potentially increasing to 150 mg or decreasing to 50 mg. Bicalutamide will be taken orally once daily at 150 mg. Treatment continues until the disease progresses. The study plans to enroll about 54-60 patients over 36 months. During the study, patients will undergo evaluations including CT scans and bone scans or PETCT to measure disease status. Researchers will monitor dose-limiting toxicities, side effects, and disease control rates over 12 weeks. Participants must meet specific health and laboratory criteria, and will be followed throughout treatment to assess safety and effectiveness of the combination therapy.

Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer