Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer, Hormone receptor positive (HR+), Human epidermal growth factor receptor 2 negative (HER2-), Breast Neoplasms, Recurrence, Alisertib, Endocrine therapy, Alisertib 50 mg, Alisertib 40 mg, Alisertib 30 mg

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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:

You CAN'T join if...

  • 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.

Locations

  • UCSF (UCSF) Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94158 United States
  • LA Cancer Network accepting new patients
    Los Angeles California 90017 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Puma Biotechnology, Inc.
ID
NCT06369285
Phase
Phase 2 Breast Cancer Research Study
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated