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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 Induced by Adjuvant Endocrine Therapy, Over 52 Weeks and Optionally for an Additional up to 2.5 Years in Women With Hormone-receptor Positive Breast Cancer

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Trial Profile

A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Induced by Adjuvant Endocrine Therapy, Over 52 Weeks and Optionally for an Additional up to 2.5 Years in Women With Hormone-receptor Positive Breast Cancer

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

Latest Information Update: 30 Jun 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

  • 24 Jun 2025 Planned End Date changed from 4 Dec 2026 to 25 Jun 2027.
  • 02 Jun 2025 According to a Bayer media release, Dr. Fatima Cardoso is the Principal Investigator of OASIS-4 trial.
  • 02 Jun 2025 According to a Bayer media release, data from this study are being presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30 -June 3 in Chicago, IL, USA, and have been simultaneously published in the New England Journal of Medicine (NEJM).

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