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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

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Trial Profile

A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 06 Mar 2025

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At a glance

  • Drugs Alisertib (Primary) ; Anastrozole; Antineoplastics; Exemestane; Fulvestrant; Letrozole; Tamoxifen
  • Indications Adenocarcinoma; Advanced breast cancer; HER2 negative breast cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms ALISCA-Breast1
  • Sponsors Puma Biotechnology

    • Most Recent Events

    • 20 Nov 2024 According to a Puma Biotechnology media release, initial data from this trial is anticipated in 2025.
    • 20 Nov 2024 According to a Puma Biotechnology media release, Puma will perform its biomarker analysis of the ALISCA-Breast1 trial in parallel with the execution of the clinical trial. Puma plans to perform an initial interim analysis for the evaluation of safety and efficacy. Based on outcomes of this trial company plans to meet with FDA regarding potential approval and engage with global regulatory agencies regarding the design of a pivotal (Phase III) trial.
    • 18 Oct 2024 Status changed from not yet recruiting to recruiting.

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