A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

Trial Profile

A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

Discontinued
Phase of Trial: Phase III

Latest Information Update: 13 Oct 2017

At a glance

  • Drugs Ribociclib (Primary) ; Letrozole
  • Indications Advanced breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms MONALEESA-2
  • Sponsors Novare Pharmaceuticals; Novartis
  • Most Recent Events

    • 12 Sep 2017 Results comparing ribociclib and palbociclib in patients with HR1, HER2 ABC using matching-adjusted indirect comparisons (MAIC) technique presented at the 42nd European Society for Medical Oncology Congress
    • 12 Sep 2017 Results presented at the 42nd European Society for Medical Oncology Congress
    • 24 Aug 2017 According to a Novartis media release, Kisqali (ribociclib) has received authorisation from the European Commission for the treatment of advanced breast cancer. Ribociclib is now licensed for use in Europe as a first-line treatment in combination with an aromatase inhibitor in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer.
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