An Open Label, Multi-center Protocol for U.S. Patients Enrolled in a Study of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative, High Risk Early Breast Cancer

Trial Profile

An Open Label, Multi-center Protocol for U.S. Patients Enrolled in a Study of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative, High Risk Early Breast Cancer

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 11 Aug 2018

At a glance

  • Drugs Ribociclib (Primary) ; Anastrozole; Exemestane; Letrozole; Tamoxifen
  • Indications Adenocarcinoma; Early breast cancer
  • Focus Adverse reactions
  • Acronyms EarLEE-1
  • Sponsors Novartis Pharmaceuticals
  • Most Recent Events

    • 23 Jul 2018 Protocol has been amended to change in Study design from Double blind to open ,change in Primary endpoint and Treatment arms.
    • 27 Mar 2018 Planned End Date changed from 13 Sep 2023 to 25 Mar 2020.
    • 27 Mar 2018 Planned primary completion date changed from 13 Sep 2023 to 25 Mar 2020.
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