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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Jul 2024

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At a glance

  • Drugs Fulvestrant (Primary) ; Ribociclib (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms MONALEESA-3
  • Sponsors Novartis; Novartis Pharmaceuticals

    • Most Recent Events

    • 04 Jun 2024 Results reporting associations of on-tx ctDNA with OS/PFS and tumor size and of ctDNA detectability with radiological progression , presented at the 60th Annual Meeting of the American Society of Clinical Oncology
    • 15 May 2024 According to a Novartis media release, data from this study will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2024 Hybrid Congress.
    • 08 Nov 2023 Results of pooled analysis from MONALEESA-2, -3, -7 assessing intrinsic subtypes with OS published in the Clinical Cancer Research

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