A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
Public ClinicalTrials.gov record NCT06369285. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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. Participants randomized prior to Amendment 4 are randomized 1:1:1 to Arm 1, Arm 2 or Arm 3. Participants randomized under Amendment 4 will be randomized 1:1 to Arm 1 or Arm 2.
Study identification
- NCT ID
- NCT06369285
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 225 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 18, 2024
- Primary completion
- Dec 29, 2027
- Completion
- Jun 29, 2029
- Last update posted
- Jul 26, 2026
2024 – 2029
United States locations
- U.S. sites
- 35
- U.S. states
- 19
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Oncology | Birmingham | Alabama | 34235 | Recruiting |
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | Recruiting |
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | Recruiting |
| MemorialCare Orange Coast Medical Center | Fountain Valley | California | 92708 | Recruiting |
| City of Hope at Orange County Lennar Foundation Cancer Center | Irvine | California | 92618 | Recruiting |
| LA Cancer Network | Los Angeles | California | 90017 | Recruiting |
| UCLA Department of Medicine - Hematology/Oncology | Los Angeles | California | 90095 | Recruiting |
| University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94158 | Recruiting |
| University of Colorado School of Medicine | Aurora | Colorado | 80045 | Recruiting |
| Yale University, Yale Cancer Center | New Haven | Connecticut | 06520 | Withdrawn |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | Recruiting |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32256 | Recruiting |
| Moffitt Cancer Center | Tampa | Florida | 33612 | Recruiting |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | Recruiting |
| University of Illinois Cancer Center | Chicago | Illinois | 60612 | Recruiting |
| The University of Chicago | Chicago | Illinois | 60637 | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | Recruiting |
| University of Minnesota, Masonic Cancer Center | Minneapolis | Minnesota | 55455 | Recruiting |
| Mayo Clinic | Rochester | Minnesota | 55905 | Recruiting |
| Missouri Cancer Associates | Columbia | Missouri | 65201 | Recruiting |
| Saint Luke's Cancer Institute | Kansas City | Missouri | 64111 | Recruiting |
| Oncology Hematology Associates | Springfield | Missouri | 65807 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Cancer Care Specialists | Reno | Nevada | 89511 | Recruiting |
| University of Rochester Medical Center | Rochester | New York | 14642 | Recruiting |
| UNC Hospitals, University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | Recruiting |
| The Ohio State University, Stefanie Spielman Comprehensive Breast Center | Columbus | Ohio | 43212 | Recruiting |
| Taylor Cancer Research Center | Maumee | Ohio | 43537 | Recruiting |
| Alliance Cancer Specialists | Horsham | Pennsylvania | 19044 | Recruiting |
| University of Pennsylvania, Abramson Cancer Center, Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | Recruiting |
| University of Pittsburgh (UPMC) | Pittsburgh | Pennsylvania | 15213 | Recruiting |
| Tennessee Oncology, Greco-Hainsworth Center for Research | Nashville | Tennessee | 37203 | Recruiting |
| Texas Oncology | Dallas | Texas | 75246 | Recruiting |
| Virginia Cancer Institute | Richmond | Virginia | 23229 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06369285, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 26, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06369285 live on ClinicalTrials.gov.