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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)

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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: 24 Jun 2025

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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

  • 18 Jun 2025 According to a Novartis Media Release, Health Canada has granted a Notice of Compliance (NOC) for KISQALI (ribociclib tablets) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of adult patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) stage II-III early breast cancer (eBC) at high risk of recurrence.
  • 01 Jun 2025 Results presented in a Novartis Media Release
  • 01 Jun 2025 According to a Novartis Media Release, subgroup analysis data will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

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