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An Open-Label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Pre- and Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

Trial Profile

An Open-Label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Pre- and Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 29 Apr 2024

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At a glance

  • Drugs Lasofoxifene (Primary) ; Fulvestrant
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Therapeutic Use
  • Acronyms ELAINE; ELAINE 1
  • Sponsors Sermonix Pharmaceuticals
  • Most Recent Events

    • 22 Apr 2024 According to a Sermonix Pharmaceuticals media release, the company announced it will host a virtual KOL fireside chat on Monday, April 22, 2024. The event will focus on the Company's ELAINE (Evaluating Lasofoxifene in ESR1 Mutations) studies investigating lasofoxifene in patients with locally advanced or metastatic estrogen receptor-positive/human epidermal growth factor 2-negative (ER+/HER2-) breast cancer expressing an estrogen receptor 1 (ESR1) mutation.
    • 16 Apr 2024 Planned End Date changed from 1 Feb 2024 to 1 Dec 2024.
    • 16 Apr 2024 Planned primary completion date changed from 1 Feb 2024 to 1 Dec 2024.
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