Alisertib

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Puma Biotechnology initiates Phase II trial of alisertib with endocrine therapy for HR+, HER2-negative metastatic breast cancer patients previously treated with CDK 4/6 inhibitors.

Puma Biotechnology initiates ALISCA-Breast1 Phase II trial of alisertib with endocrine therapy for HR+/HER2- recurrent/metastatic breast cancer post-CDK 4/6 inhibitors. Up to 150 patients will be randomized to receive alisertib at 30 mg, 40 mg, or 50 mg twice daily in 28-day cycles. Puma will analyze biomarkers to correlate with response and plans interim safety/efficacy analysis. Future plans include potential FDA approval pathway and a pivotal Phase III trial.

Puma Biotechnology initiates Phase II trial of alisertib with endocrine therapy for HR+/HER2- recurrent/metastatic breast cancer, previously treated with CDK 4/6 inhibitors. The ALISCA-Breast1 trial will randomize up to 150 patients to receive alisertib at 30 mg, 40 mg, or 50 mg twice daily in a 28-day cycle, combined with endocrine therapy. Primary endpoints include response rate, duration, disease control, progression-free survival, and overall survival. Puma will analyze biomarkers and perform an interim safety/efficacy analysis, aiming for FDA approval and a pivotal trial.