Trial Number
558-25
Condition
Breast Cancer
Participant Age Range
18 years and older
Participant Gender
Any
Enrolling Participants
Yes
Overview
“A Phase 2 Study of Alisertib in Combination with Endocrine Therapy in Patients with HR+, HER2-Negative Recurrent or Metastatic Breast Cancer”
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.