Elinzanetant found to reduce VMS from endocrine therapy for breast cancer

Elinzanetant found to reduce VMS from endocrine therapy for breast cancer | Image Credit: © highwaystarz - © highwaystarz - stock.adobe.com.

The frequency of vasomotor symptoms linked to endocrine therapy is significantly reduced by elinzanetant, according to a recent study published June 2, 2025, in the New England Journal of Medicine.¹

Impact of vasomotor symptoms

Vasomotor symptoms are commonly reported in women taking endocrine therapy to treat or prevent hormone-receptor (HR)-positive breast cancer. According to Ann Partridge, MD, PhD, up to 90% of this population experience vasomotor symptoms.²

“Menopausal symptoms not only affect quality of life among survivors of breast cancer, but also may have indirect adverse effects on disease-free and overall survival, especially if the symptoms lead to nonadherence to risk-reducing endocrine therapy,” wrote Partridge.²

Partridge also highlighted a cross-sectional study that reported reduced adherence to endocrine therapy among patients with more severe vasomotor symptoms, indicating a vital need for management. While elinzanetant has been indicated as effective for vasomotor symptom treatment, its efficacy has not been evaluated in patients receiving endocrine therapy.¹

Elinzanetant vs placebo

The phase 3 trial was conducted to address this research gap. Participants included women aged 18 to 70 years reporting moderate-to-severe vasomotor symptoms caused by endocrine therapy for HR-positive breast cancer treatment or prevention.¹

These patients were randomized 2:1 to receive either an elinzanetant 120 mg dose once per day for 52 weeks or a placebo dose once per day for 12 weeks, followed by the elinzanetant regimen for 40 weeks. The changes in the average frequency of moderate-to-severe vasomotor symptoms between baseline and weeks 4 and 12 were reported as the primary outcome.¹

There were 316 patients included in the elinzanetant group and 158 in the placebo-elinzanetant group. These patients reported a mean of 11.4 and 11.5 respective episodes of moderate-to-severe vasomotor symptoms per day.¹

Significant reduction in symptom frequency

Mean changes in daily moderate-to-severe vasomotor symptom episodes from baseline to week 4 were -6.5 and -3, respectively. This indicated a least-squares mean difference of -3.5 episodes.¹

In comparison, the elinzanetant group reported a mean change in daily moderate-to-severe vasomotor episodes of -7.8 at week 12, vs -4.2 among the placebo group. This indicated a least-squares mean difference of -3.4 episodes.¹

The occurrence of at least 1 adverse event was reported in 69.8% of patients in the elinzanetant group and 62% in the placebo group from week 1 to week 12. Common adverse events included fatigue, headache, and somnolence. In the elinzanetant and placebo groups, 2.5% and 0.6% of patients, respectively, reported severe adverse events.¹

Improved quality of life

Elinzanetant was also linked to more significant improvements in sleep quality and menopausal quality of life at week 12 vs placebo.² In the placebo group, these improvements were also reported after switching to elinzanetant.

Partridge noted that postmenopausal hormonal therapy is often used to treat vasomotor symptoms, and this treatment is largely contraindicated in breast cancer patients. Lifestyle and behavior therapies that may help reduce symptoms in this population include acupuncture, cognitive behavioral therapy, and hypnosis.²

“This randomized, controlled trial provides efficacy and safety findings for [elinzanetant] among women with breast cancer, and the findings inform the potential role of this agent in ameliorating vasomotor symptoms in this population,” wrote Partridge.²

References

1. Cardoso F, Parke S, Brennan DJ, et al. Elinzanetant for vasomotor symptoms from endorine therapy for breast cancer. The New England Journal of Medicine. 2025. doi:10.1056/NEJM.org
2. Partridge AH. Menopausal symptom management in breast cancer survivors— A promising new option. The New England Journal of Medicine. June 2, 2025. Accessed June 3, 2025.