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A Randomized, Placebo-controlled, Double-blind, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms (Hot Flashes) in Women With Stage 0 to 3 Hormone Receptor-positive Breast Cancer Who Are Receiving Adjuvant Endocrine Therapy

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A Randomized, Placebo-controlled, Double-blind, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms (Hot Flashes) in Women With Stage 0 to 3 Hormone Receptor-positive Breast Cancer Who Are Receiving Adjuvant Endocrine Therapy

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Apr 2025

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At a glance

  • Drugs Fezolinetant (Primary) ; Aromatase inhibitors; Tamoxifen
  • Indications Hot flashes
  • Focus Registrational; Therapeutic Use
  • Acronyms HIGHLIGHT 1
  • Sponsors Astellas Pharma; Astellas Pharma Global Development

    • Most Recent Events

    • 06 Feb 2025 Planned End Date changed from 31 Aug 2027 to 30 Sep 2028.
    • 06 Feb 2025 Planned primary completion date changed from 31 Oct 2026 to 30 Nov 2026.
    • 10 Oct 2024 According to Astellas Pharma media release,trial design will be presented during the International Menopause Society (IMS) 19th World Congress on Menopause in Melbourne, Australia, October 19-22.

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