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NCT06369285 · ClinicalTrials.gov registry record · Phase 2
A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
A Phase 2 study of Metastatic Breast Cancer and Recurrent Breast Cancer, sponsored by Puma Biotechnology.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT06369285 is a Phase 2 study of Metastatic Breast Cancer and Recurrent Breast Cancer that is actively recruiting participants, run by Puma Biotechnology. The registered enrollment target is 150 participants, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (26% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT06369285, a Phase 2 study of Metastatic Breast Cancer and Recurrent Breast Cancer, is actively recruiting participants, sponsored by Puma Biotechnology.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Endocrine therapy
- DRUG Alisertib
Study Locations (20)
California
- Beverly Hills Cancer Center - Beverly Hills
- MemorialCare Orange Coast Medical Center - Fountain Valley
- City of Hope at Orange County Lennar Foundation Cancer Center - Irvine
- LA Cancer Network - Los Angeles
- UCLA Department of Medicine - Hematology/Oncology - Los Angeles
- University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center - San Francisco
Florida
- Mayo Clinic Florida - Jacksonville
- Cancer Specialists of North Florida - Jacksonville
- Moffitt Cancer Center - Tampa
Illinois
- University of Illinois Cancer Center - Chicago
- The University of Chicago - Chicago
Massachusetts
- Massachusetts General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Minnesota
- University of Minnesota, Masonic Cancer Center - Minneapolis
- Mayo Clinic - Rochester
Alabama
- Alabama Oncology - Birmingham
Arizona
- Mayo Clinic Hospital - Phoenix
Colorado
- University of Colorado School of Medicine - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-11-19 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06369285
The ClinicalTrials.gov registry entry for NCT06369285 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (26% lower). The listed sponsor is Puma Biotechnology, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Endocrine therapy is the first listed.
NCT06369285 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT06369285 about?
NCT06369285 is a clinical study titled "A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer". 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...
What is the current status of trial NCT06369285?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2024-11-19. Estimated completion is 2028-12-31.
What conditions does trial NCT06369285 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, Recurrent Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer.
What interventions are being tested in trial NCT06369285?
The interventions under investigation include: Endocrine therapy (DRUG), Alisertib (DRUG).
Who is sponsoring clinical trial NCT06369285?
This trial is sponsored by Puma Biotechnology, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06369285 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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