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A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

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A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Mar 2024

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At a glance

  • Drugs Ribociclib (Primary) ; Anastrozole; Goserelin; Letrozole; Tamoxifen
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms MONALEESA-7
  • Sponsors Novartis Farma; Novartis Healthcare; Novartis Pharmaceuticals

    • Most Recent Events

    • 24 Feb 2024 This trial has been completed in Portugal, according to European Clinical Trials Database record.
    • 13 Feb 2024 Primary endpoint has been amended.
    • 08 Nov 2023 Results of pooled analysis from MONALEESA-2, -3, -7 assessing intrinsic subtypes with OS published in the Clinical Cancer Research.

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