The trial is set to enrol up to 150 subjects who will be randomly assigned to one of three dosing regimens of alisertib. Credit: S_L/Shutterstock.

Puma Biotechnology has commenced the Phase II trial, ALISCA-Breast1, to evaluate oral alisertib, a selective inhibitor of aurora kinase A, for breast cancer treatment.

In this trial, alisertib will be assessed in conjunction with endocrine therapy for treating individuals having hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-negative) recurrent or metastatic breast cancer.

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These subjects were earlier treated with cyclin-dependent kinase (CDK)4/6 inhibitors and received endocrine therapy.

The trial is set to enrol up to 150 subjects. They will be randomly assigned to one of three dosing regimens of alisertib—30mg, 40mg, or 50mg—administered twice daily on a specified schedule alongside the endocrine therapy chosen by the investigator.

Subjects are required to provide blood and tissue samples for biomarker analysis.

The main objective is to identify the optimal dosage of alisertib when used with endocrine therapy. The primary endpoints include measuring the duration of response, objective response rate, disease control rate, overall survival rates, and progression-free survival.

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For the secondary endpoint, the company aims to assess the efficacy endpoints within biomarker subgroups to identify any potential correlation between biomarkers and response rates.

The biomarker analysis is set to be conducted concurrently with the clinical trial, including an initial interim analysis for safety and efficacy assessment.

If the trial outcomes are positive, the company anticipates discussing an approval pathway with the US Food and Drug Administration (FDA) for the therapy in treating breast cancer.

Puma Biotechnology president, founder and CEO Alan Auerbach said: “We believe that the data from the previous trial of alisertib monotherapy as well as the TBCRC 041 trial which tested alisertib alone and with fulvestrant, and the randomised trial of alisertib plus paclitaxel versus paclitaxel alone have demonstrated that alisertib is active in patients with HER2-negative, HR+ metastatic breast cancer and in biomarker focused subgroups.

“We look forward to enrolment in the ALISCA-Breast1 trial and anticipate that we should have initial data from this trial in 2025.”

Following the determination of the optimal dose, the company intends to consult with global regulatory bodies to design a pivotal Phase III trial.

In February, the company began the Phase II trial, ALISCA-Lung1, for alisertib monotherapy in individuals with extensive-stage small-cell lung cancer.