Combining Alisertib with Endocrine Therapy for Advanced Breast Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of alisertib, a targeted therapy, when used alongside endocrine therapy in patients with hormone receptor-positive, HER2-negative metastatic breast cancer. Participants must have previously progressed on at least two lines of endocrine therapy. The study aims to determine the optimal dose of alisertib and assess its safety, efficacy, and pharmacokinetics, while also identifying specific patient subgroups that may benefit the most from this combination treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged ≥18 years at signing of informed consent.
* Pathology-confirmed diagnosis of breast cancer 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, including antibody drug conjugates with a chemotherapeutic payload.
* 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.

Where it's running

• Alabama Oncology
  Birmingham, Alabama, United States Recruiting
• Mayo Clinic Hospital
  Phoenix, Arizona, United States Recruiting
• Beverly Hills Cancer Center
  Beverly Hills, California, United States Recruiting
• MemorialCare Orange Coast Medical Center
  Fountain Valley, California, United States Recruiting
• City of Hope at Orange County Lennar Foundation Cancer Center
  Irvine, California, United States Recruiting
• LA Cancer Network
  Los Angeles, California, United States Recruiting

+3 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Puma Biotechnology, Inc. Clinical Operations Senior Director
• Email: ClinicalTrials@pumabiotechnology.com
• Phone: 424-248-6500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.