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

Trial Profile

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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Mar 2018

At a glance

  • Drugs Ribociclib (Primary) ; Anastrozole; Goserelin; Letrozole; Tamoxifen
  • Indications Advanced breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms MONALEESA-7
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 03 Jan 2018 According to a Novartis media release, based on results from this trial, Kisqali (ribociclib) has received US Food and Drug Administration (FDA) Breakthrough Therapy designation for initial endocrine-based treatment of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor.
    • 30 Dec 2017 Planned End Date changed from 27 Feb 2018 to 27 Aug 2019.
    • 30 Dec 2017 Planned primary completion date changed from 27 Feb 2018 to 27 Aug 2019.
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