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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

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: Discontinued
Phase of Trial: Phase III

Latest Information Update: 31 May 2020

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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

    • 31 May 2020 Results (n=1503) of pooled ctDNA analysis from three MONALEESA trials: ML-2, ML-3 and ML-7 assessing potential biomarkers of response or resistance to ribociclib presented at the 56th Annual Meeting of the American Society of Clinical Oncology
    • 27 May 2020 According to an Novartis media release, pooled analysis data from the MONALEESA trials will be presented during the ASCO20 Virtual Scientific Program
    • 14 Dec 2019 Results assessing the potential for drug-drug interactions (DDIs) by comparing steady-state exposures data from study X2101 (NCT01237236) for Ribociclib alone with those of Ribociclib when used in combination with endocrine therapy in hormone receptor-positive, advanced breast cancer patients from four studies (NCT01872260,NCT01958021,NCT02278120 and NCT02422615), were presented at the 42nd Annual San Antonio Breast Cancer Symposium.
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