Puma Biotechnology has announced the initiation of the ALISCA-Breast1 Phase II trial (PUMA-ALI-1201; NCT06369285) to assess the efficacy and safety of alisertib in combination with endocrine therapy for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) recurrent or metastatic breast cancer. This patient population has previously been treated with CDK 4/6 inhibitors and has received at least two prior lines of endocrine therapy in the recurrent or metastatic setting.
The ALISCA-Breast1 trial aims to enroll up to 150 patients. Participants will be randomized in a 1:1:1 ratio to receive alisertib at doses of 30 mg, 40 mg, or 50 mg twice daily on days 1-3, 8-10, and 15-17 of a 28-day cycle, combined with the investigator's choice of endocrine therapy.
Biomarker Analysis and Regulatory Strategy
Puma Biotechnology plans to conduct biomarker analysis of the ALISCA-Breast1 trial concurrently with the clinical trial execution. This analysis aims to identify potential biomarker subgroups that correlate with response to alisertib. An initial interim analysis will be performed to evaluate safety and efficacy.
Based on the trial outcomes, Puma intends to engage with the U.S. Food and Drug Administration (FDA) to explore potential approval pathways for alisertib in HER2-negative, HR+ metastatic breast cancer. Following the identification of the optimal alisertib dose, Puma plans to consult with global regulatory agencies regarding the design of a pivotal Phase III trial. The anticipated Phase III trial will be a randomized study comparing alisertib plus investigator's choice endocrine therapy versus placebo plus investigator's choice endocrine therapy in patients with HER2-negative, HR+ metastatic breast cancer.
