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

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

Trial Details

NCT ID
NCT06369285
Phase
PHASE2
Sponsor
Puma Biotechnology, Inc.
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Alisertib
  • Endocrine therapy
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Beverly Hills, California, United States|34.07362,-118.40036
  • Fountain Valley, California, United States|33.70918,-117.95367
  • Irvine, California, United States|33.66946,-117.82311

Key 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 disea…
  • Participants must have received a CDK4/6i in combination with endocrine therapy in the recurrent or metastatic setting.

For full eligibility, visit ClinicalTrials.gov.

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