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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Mar 2025

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At a glance

  • Drugs Ribociclib (Primary) ; Letrozole
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms MONALEESA-2
  • Sponsors Novare Pharmaceuticals; Novartis

Most Recent Events

  • 08 Nov 2023 Results of pooled analysis from MONALEESA-2, -3, -7 assessing intrinsic subtypes with OS published in the Clinical Cancer Research
  • 24 Oct 2023 Results of analysis of final overall survival (OS) of MONALEESA-2 (ML-2) and PALOMA assessing cost-effectiveness of ribociclib vs palbociclib presented at the 48th European Society for Medical Oncology Congress.
  • 04 Sep 2023 Results of pooled analysis from MONALEESA phase III trials assessing potential biomarkers of response to ribociclib published in the Annals of Oncology.

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