Clinical Trials

Our Mission

Puma Biotechnology is a biopharmaceutical company dedicated to the acquisition, development, and commercialization of novel therapeutics for the treatment of cancer.

Clinical Trials

ALISCA™-Breast1

In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, an investigational, selective, small molecule, orally administered inhibitor of Aurora Kinase A. In March 2024, Puma received FDA approval to proceed with our Phase II ALISCA™-Breast1 trial of alisertib for the treatment of hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer.

Metastatic Breast Cancer

ALISCA™-Breast1

A Phase II Study of Alisertib, an Investigational Drug, in Combination with Endocrine Therapy in Patients with HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer.

ABOUT THIS CLINICAL TRIAL

This Phase II study is investigating alisertib in combination with endocrine therapy in patients with HR+, HER2-negative metastatic breast cancer (MBC). Findings from this study are anticipated to identify the optimal alisertib dose level administered in combination with selected endocrine therapy to be used in future studies based on safety and efficacy, as well as identify a biomarker subpopulation of patients who derive the greatest benefit from combined alisertib and endocrine therapy.

WHO IS ELIGIBLE?

The ALISCA™-Breast1 clinical trial is open to patients 18 years or older with pathologically confirmed recurrent or metastatic HR+, HER2-negative breast cancer who have received at least two prior lines of endocrine therapy including a CDK4/6i in combination with endocrine therapy in the recurrent or metastatic setting, but who have not received chemotherapy in the recurrent or metastatic setting. Talk to your doctor to discuss your eligibility.