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Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 1, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT06369285). This is a study registration, not published results. Lead sponsor: Puma Biotechnology, Inc.. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 225 participants (ESTIMATED). Conditions: Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer. Interventions: DRUG: Alisertib; DRUG: Endocrine therapy. Primary outcome measures: Objective Response Rate (ORR) Within Dose Subgroup , From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months; Duration of Response (DOR) Within Dose Subgroup , From start date of response (after date of randomization) to first PD, assessed up to 48 months; Disease Control Rate (DCR) Within Dose Subgroup , From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months; Progression Free Survival (PFS) Within Dose Subgroup , From date of randomization to date of recurrence, progression or death, assessed up to 48 months; Overall Survival (OS) Within Dose Subgroup , From date of randomization to death, assessed up to 48 months; Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the Enrolled Population , From date of first dose through last dose plus 28 days, assessed up to 48 months. Brief 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. Participants randomized prior to Amendment 4 are randomized 1:1:1 to Arm 1, Arm 2 or Arm 3. Participants randomized under Amendment 4 will be randomized 1:1 to Arm 1 or Arm 2.