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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: Recruiting Phase 2 study of Metastatic Breast Cancer and Recurrent Breast Cancer, sponsored by Puma Biotechnology.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study.

Conditions Studied

Metastatic Breast Cancer Recurrent Breast Cancer Hormone Receptor Positive HER-2 Negative Breast Cancer

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

FieldValue
Enrollment Target 150 participants
Start Date 2024-11-19
Est. Completion 2028-12-31
Phase Phase 2
Puma Biotechnology

28 total trials

What NCT06369285 shows while recruiting

NCT06369285 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (26% lower).

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 names 20 study sites across 10 states, led by 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.

Learn More About Clinical Trials

Similar trials for Metastatic Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06369285's enrollment target sits among peer trials

150 43rd of 139 higher than 97 of 139 other Metastatic Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06369285

Source: ClinicalTrials.gov NCT06369285, the US trial registry maintained by the National Library of Medicine. NCT06369285 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.