A Randomized Double-blind, Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment

Trial Profile

A Randomized Double-blind, Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Apr 2017

At a glance

  • Drugs Fulvestrant (Primary) ; Ribociclib (Primary)
  • Indications Advanced breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms MONALEESA-3
  • Sponsors Novartis; Novartis Pharma A.G.
  • Most Recent Events

    • 03 Aug 2016 According to a Novartis media release, this trial is fully enrolled.
    • 03 Aug 2016 According to a Novartis media release, status changed from recruiting to active, no longer recruiting.
    • 28 Jul 2016 Planned End Date changed from 1 Nov 2016 to 1 Feb 2020.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top