A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative, High Risk Early Breast Cancer

Trial Profile

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative, High Risk Early Breast Cancer

Recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Aug 2017

At a glance

  • Drugs Ribociclib (Primary)
  • Indications Adenocarcinoma; Breast cancer
  • Focus Therapeutic Use
  • Acronyms EarLEE-1
  • Sponsors Novartis Pharmaceuticals
  • Most Recent Events

    • 28 Jul 2017 Planned End Date changed from 21 Aug 2023 to 13 Sep 2023.
    • 28 Jul 2017 Planned primary completion date changed from 21 Aug 2023 to 13 Sep 2023.
    • 28 Jun 2017 Planned End Date changed from 31 Jul 2023 to 21 Aug 2023.
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