Elinzanetant Reduces Hot Flashes in HR+ Breast Cancer: Daily Dose

Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.

On June 3, 2025, we reported on new data from the OASIS-4 clinical trial presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, the first international phase 3 study that examined the safety and efficacy of elinzanetant for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with endocrine therapy for the treatment or prevention of HR+ breast cancer.

The study

The fourth study in the OASIS clinical trial program randomized 474 women aged 18 to 70 years across 90 international sites (excluding the US) to receive elinzanetant 120 mg once daily (n = 316) or placebo for 12 weeks followed by elinzanetant for 40 weeks (n = 158). Eligible participants were on endocrine therapy—either tamoxifen or aromatase inhibitors—with or without gonadotropin-releasing hormone analogues, and experiencing at least 35 moderate-to-severe VMS per week.

The findings

At baseline, the mean daily frequency of moderate-to-severe VMS was 11.4 episodes (95% CI, 10.7–12.2) in the elinzanetant group and 11.5 (95% CI, 10.5–12.5) in the placebo group. By week 4, the frequency decreased by −6.5 episodes (95% CI, −7.2 to −5.8) in the elinzanetant group and −3.0 episodes (95% CI, −3.9 to −2.2) in the placebo group (least-squares mean difference, −3.5; 95% CI, −4.4 to −2.6; P < .001). At week 12, the reductions were −7.8 (95% CI, −8.5 to −7.1) and −4.2 (95% CI, −5.2 to −3.2), respectively (least-squares mean difference, −3.4; 95% CI, −4.2 to −2.5; P < .001).

Elinzanetant also showed benefit as early as week 1, reducing VMS frequency by −4.0 episodes (95% CI, −4.6 to −3.5) compared to −1.8 (95% CI, −2.4 to −1.2) with placebo. A ≥50% reduction in VMS was observed in 74.3% of patients receiving elinzanetant at week 12, compared to 35.8% with placebo.

Authors' comments

"These results are consistent with the previously published phase 3 trials involving women with vasomotor symptoms caused by natural or surgically induced menopause, which shows the reproducibility of findings across populations."

Click here for more details.