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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

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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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 May 2023

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At a glance

  • Drugs Ribociclib (Primary) ; Fulvestrant; Goserelin; Letrozole; Tamoxifen
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Adverse reactions
  • Acronyms MONALEESASIA
  • Sponsors Novartis; Novartis Pharmaceuticals

Most Recent Events

  • 25 Oct 2022 Status changed from active, no longer recruiting to completed.
  • 02 Sep 2022 Planned End Date changed from 12 Aug 2022 to 30 Sep 2022.
  • 02 Sep 2022 Planned primary completion date changed from 13 Jul 2022 to 30 Sep 2022.

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