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: 23 Jun 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

    • 23 Jun 2017 According to a Novartis media release, Kisqali (ribociclib) receives positive CHMP opinion as first-line treatment for HR+/HER2- locally advanced or metastatic breast cancer in combination with any aromatase inhibitor.
    • 02 Jun 2017 Results published in a Novartis media release.
    • 02 Jun 2017 Results (n=664) presenting safety analysis presented at the 53rd Annual Meeting of the American Society of Clinical Oncology.
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