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A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)

Trial Profile

A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 22 Mar 2024

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At a glance

  • Drugs Ribociclib (Primary) ; Anastrozole; Goserelin; Letrozole
  • Indications Adenocarcinoma; Early breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms NATALEE
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 20 Mar 2024 According to an UCLAs Jonsson Comprehensive Cancer Center media release, results of prespecified interim analysis of invasive disease from this trial were published today in the New England Journal of Medicine.
    • 31 Jan 2024 According to a Novartis media release, data of this study data submitted to the FDA in December 2023.
    • 31 Jan 2024 According to a Novartis media release, data from this study presented at the SABCS 2023.
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