A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer

Launched by PUMA BIOTECHNOLOGY, INC. · Apr 12, 2024

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ClinConnect Summary

This clinical trial, called PUMA-ALI-1201, is studying a medication called alisertib when used together with hormone therapy for patients who have a specific type of breast cancer known as hormone receptor-positive, HER2-negative metastatic breast cancer. This trial is for adults who have already received at least two prior hormone treatments but have seen their cancer progress. The goal is to find out the best dose of alisertib to use with hormone therapy and to see how effective and safe this combination can be. Researchers will also look for specific patient characteristics that may help predict who will benefit the most from this treatment.

To participate, you need to be at least 18 years old and have a confirmed diagnosis of breast cancer that has come back or spread, making it not curable with standard treatments. You should have already been treated with hormone therapy and a specific type of targeted therapy called CDK4/6 inhibitors. However, if you have recently had chemotherapy or have been treated with alisertib or similar medications in the past, you may not be eligible. If you decide to join the study, you will receive regular check-ups and monitoring to ensure your safety while evaluating the treatment's effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged ≥18 years at signing of informed consent.
• • Pathology-confirmed diagnosis of adenocarcinoma of the breast with evidence of recurrent or metastatic disease not amenable to curative therapy.
• • Progression on or after treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting. a. If metastatic disease recurrence occurs during or within six months of discontinuing adjuvant endocrine therapy, then that endocrine therapy will count as one line of prior therapy.
• • Participants must have received a CDK4/6i in combination with endocrine therapy in the recurrent or metastatic setting.
• * HR-positive and HER2-negative tumor status reported per local laboratory testing. HR and HER2 testing must be performed consistent with current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) or European Society of Medical Oncology (ESMO) guidelines:
• Exclusion Criteria:
• • Treatment with chemotherapy in the recurrent or metastatic setting.
• • Prior treatment with an Aurora Kinase A (AURKA) specific-targeted or pan-Aurora-targeted agent, including alisertib, in any setting.
• • Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.