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

Description

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

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Hormone Receptor Positive HER-2 Negative Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Birmingham

Alabama Oncology, Birmingham, Alabama, United States, 34235

Phoenix

Mayo Clinic Hospital, Phoenix, Arizona, United States, 85054

Los Angeles

LA Cancer Network, Los Angeles, California, United States, 90017

San Francisco

University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States, 94158

New Haven

Yale University, Yale Cancer Center, New Haven, Connecticut, United States, 06520

Jacksonville

Mayo Clinic Florida, Jacksonville, Florida, United States, 32224

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Maumee

Taylor Cancer Research Center, Maumee, Ohio, United States, 43537

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Puma Biotechnology, Inc.,

Chief Reg Affairs, PV, Medical Affairs and Law Officer, STUDY_DIRECTOR, Puma Biotechnology, Inc.

Study Record Dates

2028-12-31