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

Active:	Yes
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT06369285
Trial Phases:	Phase II	Protocol IDs:	PUMA-ALI-1201 (primary) NCI-2024-06850 2024-511497-79-00
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Puma Biotechnology, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT06369285

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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