NCT06369285 A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
| NCT ID | NCT06369285 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Puma Biotechnology, Inc. |
| Condition | Hormone Receptor Positive HER-2 Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-11-19 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2024-11-19 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy.
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.
Contact & Investigator
Puma Biotechnology, Inc. Clinical Operations Senior Director
✉ ClinicalTrials@pumabiotechnology.com📞 424-248-6500
Chief Reg Affairs, PV, Medical Affairs and Law Officer
STUDY DIRECTOR
Puma Biotechnology, Inc.
Frequently Asked Questions
Who can join the NCT06369285 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hormone Receptor Positive HER-2 Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06369285 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06369285 currently recruiting?
Yes, NCT06369285 is actively recruiting participants. Contact the research team at ClinicalTrials@pumabiotechnology.com for enrollment information.
Where is the NCT06369285 trial being conducted?
This trial is being conducted at Birmingham, United States, Phoenix, United States, Beverly Hills, United States, Fountain Valley, United States and 11 additional locations.
Who is sponsoring the NCT06369285 clinical trial?
NCT06369285 is sponsored by Puma Biotechnology, Inc.. The principal investigator is Chief Reg Affairs, PV, Medical Affairs and Law Officer at Puma Biotechnology, Inc.. The trial plans to enroll 150 participants.
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