Home › Trials › NCT06369285

Combining Alisertib with Endocrine Therapy for Advanced Breast Cancer

A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer

Phase 2 Interventional Puma Biotechnology, Inc. · NCT06369285

This study is testing if adding a targeted therapy called alisertib to hormone treatment can help people with advanced breast cancer who haven’t responded to previous hormone therapies.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorPuma Biotechnology, Inc. Industry-sponsored
Drugs / interventionschemotherapy
Locations53 sites (Birmingham, Alabama and 52 other locations)
Trial IDNCT06369285 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed HR-positive, HER2-negative metastatic breast cancer who have progressed after at least two prior endocrine therapies.

Not a fit: Patients with chemotherapy treatment in the recurrent or metastatic setting may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced breast cancer who have limited treatment choices.

How similar studies have performed: Other studies have explored similar combinations of targeted therapies and endocrine treatments, showing promising results, but this specific approach is still being evaluated.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hormone Receptor Positive HER-2 Negative Breast CancerMetastatic Breast CancerRecurrent Breast CancerHormone receptor positiveHuman epidermal growth factor receptor 2 negative
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.