Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer (OASIS-4)

Tier 2: Professional organization or credentialed expert guidance
Publisher: New England Journal of Medicine · Published: August 21, 2025 · Accessed: September 4, 2026

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• In a phase 3 trial (OASIS-4, NCT05587296), 474 women aged 18-70 with moderate-to-severe vasomotor symptoms associated with endocrine therapy for HR-positive breast cancer (or its prevention) were randomized 2:1 to elinzanetant 120 mg daily or placebo. Mean baseline frequency was about 11.4-11.5 moderate-to-severe episodes per day.
• Mean daily frequency of moderate-to-severe vasomotor symptoms fell by 6.5 episodes at week 4 and 7.8 at week 12 with elinzanetant, versus 3.0 and 4.2 with placebo (between-group difference about 3.5 and 3.4 episodes; P<0.001 for both).
• Most common adverse events with elinzanetant were headache, fatigue, and somnolence; serious adverse events occurred in 2.5% of the elinzanetant group versus 0.6% of the placebo group during weeks 1-12.
• Funded by Bayer. Published NEJM 2025 Aug 21;393(8):753-763; PMID 40454634.