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A Phase 2 study of alisertib in combination with endocrine therapy in patients with HR+, HER2-negative recurrent or metastatic breast cancer

Primary Objective

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.

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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.

Details
Age
Adult
Eligibility
Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT06369285
Locations

Cherry Creek Medical Center
CTRC Inpatient
Highlands Ranch Hospital
Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Jennifer Diamond

Jennifer Diamond

Study ID

Protocol Number: 24-1686

More information available at ClinicalTrials.gov: NCT06369285

Categories

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