N Engl J Med

ASCO 2025: Nonhormonal drug cuts hot flashes triggered by breast cancer therapy

June 5, 2025

Elinzanetant offered a well-tolerated, nonhormonal treatment for vasomotor symptoms (VMS) in breast cancer patients in a phase 3 trial, addressing a key quality-of-life issue and potentially improving adherence to endocrine therapy. These results were shared at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago.

Study details: In the phase 3 OASIS-4 trial (NCT05587296), 474 women with moderate-to-severe VMS related to endocrine therapy for HR-positive breast cancer or its prevention were randomized 2:1 to receive elinzanetant 120 mg daily or placebo. Primary endpoints were changes in mean daily frequency of moderate-to-severe VMS at weeks 4 and 12.

Results: At baseline, both groups reported ~11.4 daily VMS episodes. By week 4, elinzanetant reduced VMS by 6.5 episodes/day vs. 3.0 with placebo (difference: -3.5; P<0.001). At week 12, reductions were 7.8 vs. 4.2 episodes/day (difference: -3.4; P<0.001). Adverse events were mostly mild, and serious events were rare (2.5% vs. 0.6%).

Source:

Cardoso F, et al. (2025, June 2). N Engl J Med. Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer. https://pubmed.ncbi.nlm.nih.gov/40454634/