A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

Trial Profile

A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 21 Feb 2018

At a glance

  • Drugs Ribociclib (Primary) ; Fulvestrant; Goserelin; Letrozole; Tamoxifen
  • Indications Advanced breast cancer
  • Focus Adverse reactions
  • Acronyms MONALEESASIA
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 15 Feb 2018 Planned primary completion date changed from 6 Sep 2018 to 1 Oct 2018.
    • 09 Dec 2017 Results of Asian non-Japanese patients (n=26; as of 16 Jan 2017) presented at the 40th Annual San Antonio Breast Cancer Symposium
    • 28 Jun 2017 Planned End Date changed from 12 Apr 2019 to 5 Oct 2018.
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