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A Phase II Trial of OnapriStone in CoMbInation With FuLvestrant for Patients With ER-positive, and HER2-negative Metastatic Breast Cancer After Progression on Endocrine Therapy and CDK 4/6 Inhibitors

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Trial Profile

A Phase II Trial of OnapriStone in CoMbInation With FuLvestrant for Patients With ER-positive, and HER2-negative Metastatic Breast Cancer After Progression on Endocrine Therapy and CDK 4/6 Inhibitors

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 06 May 2024

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At a glance

  • Drugs Fulvestrant (Primary) ; Onapristone (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Therapeutic Use
  • Acronyms SMILE; The SMILE Study

Most Recent Events

  • 30 Oct 2023 Status changed from active, no longer recruiting to discontinued.
  • 18 May 2023 Status changed from recruiting to active, no longer recruiting.
  • 10 Dec 2022 Trial design presented at the 45th Annual San Antonio Breast Cancer Symposium.

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