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A double-blind, randomized, placebo-controlled multicenter study to investigate efficacy and safety of elinzanetant for the treatment of vasomotor symptoms caused by adjuvant endocrine therapy, over 52 weeks and Optionally for Additional 2 Years in women with, or at high risk for developing hormone-receptor positive breast cancer

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A double-blind, randomized, placebo-controlled multicenter study to investigate efficacy and safety of elinzanetant for the treatment of vasomotor symptoms caused by adjuvant endocrine therapy, over 52 weeks and Optionally for Additional 2 Years in women with, or at high risk for developing hormone-receptor positive breast cancer

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

Latest Information Update: 07 Feb 2025

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At a glance

  • Drugs Elinzanetant (Primary)
  • Indications Vasomotor symptoms
  • Focus Registrational; Therapeutic Use
  • Acronyms OASIS 4
  • Sponsors Bayer

    • Most Recent Events

    • 14 Jan 2025 According to Bayer media release, the company anticipates detailed results from OASIS 4 are planned to be presented at an upcoming scientific congress.
    • 09 Jan 2025 Primary endpoint has been met. (Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD)).
    • 09 Jan 2025 Primary endpoint has been met. (Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD]).

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