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A Phase II, Multicenter, Randomized, Open-label Study to Evaluate the Safety and Efficacy of 400 mg of Ribociclib in Combination With Non-steroidal Aromatase Inhibitors for the Treatment of Pre- and Postmenopausal Women With Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

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Trial Profile

A Phase II, Multicenter, Randomized, Open-label Study to Evaluate the Safety and Efficacy of 400 mg of Ribociclib in Combination With Non-steroidal Aromatase Inhibitors for the Treatment of Pre- and Postmenopausal Women With Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 29 Nov 2024

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At a glance

  • Drugs Ribociclib (Primary) ; Anastrozole; Goserelin; Letrozole
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Therapeutic Use
  • Acronyms AMALEE
  • Sponsors Novartis; Novartis Healthcare; Novartis Pharmaceuticals
  • Most Recent Events

    • 16 Oct 2024 Status changed from active, no longer recruiting to completed.
    • 23 Sep 2024 This trial has been completed in Lithuania, according to European Clinical Trials Database record.
    • 20 Sep 2024 This trial has been completed in France (Global end date: 2024-08-30) according to European Clinical Trials Database record.

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