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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-negartive 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-negartive Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Dec 2019

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At a glance

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

    • 05 Dec 2019 According to a Novartis media release, the potential registration is expected in 2022 based on the interim results.
    • 04 Jun 2019 Study design was presented at the 55th Annual Meeting of the American Society of Clinical Oncology.
    • 22 Apr 2019 Planned primary completion date changed from 26 Nov 2025 to 26 Dec 2025.
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