Elinzanetant cuts vasomotor symptoms in women with breast cancer on endocrine therapy

For women with moderate-to-severe vasomotor symptoms associated with endocrine therapy for hormone receptor (HR)-positive breast cancer, elinzanetant, a neurokinin-targeted therapy, reduces the frequency of vasomotor symptoms, according to a study published online June 2 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago.

Fatima Cardoso, M.D., from the Champalimaud Foundation in Lisbon, Portugal, and colleagues performed a phase 3 trial involving women aged 18 to 70 years with moderate-to-severe vasomotor symptoms associated with endocrine therapy for HR-positive breast cancer or its prevention.

Women were randomly assigned to receive once-daily elinzanetant at a dose of 120 mg for 52 weeks or once-daily placebo for 12 weeks followed by once-daily elinzanetant at a dose of 120 mg for 40 weeks (316 and 158 patients, respectively). Only one of the patients was taking endocrine therapy for breast cancer prevention.

The researchers found that the mean change from baseline in the mean daily frequency of moderate-to-severe vasomotor symptoms at week 4 was −6.5 and −3.0 episodes for those receiving elinzanetant and placebo, respectively (least-squares mean difference, −3.5 episodes). The mean change was −7.8 and −4.2 episodes among those receiving elinzanetant and placebo, respectively, at week 12 (least-squares mean difference, −3.4 episodes).

Overall, 69.8% and 62.0% of those receiving elinzanetant and placebo, respectively, reported at least one adverse event during weeks 1 through 12; serious adverse events occurred in 2.5% and 0.6%, respectively.

“In a finding consistent with the results of previous trials involving postmenopausal women, treatment with elinzanetant resulted in significant decreases in the frequency of vasomotor symptoms and in sleep disturbances and improvements in health-related quality of life among women with moderate-to-severe vasomotor symptoms taking endocrine therapy for breast cancer,” the authors write.

Several authors disclosed ties to Bayer, which is developing elinzanetant and funded the study.

Copyright © 2025 HealthDay. All rights reserved.

For women with moderate-to-severe vasomotor symptoms associated with endocrine therapy for hormone receptor (HR)-positive breast cancer, elinzanetant, a neurokinin-targeted therapy, reduces the frequency of vasomotor symptoms, according to a study published online June 2 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Clinical Oncology, held from May 31 to June 4 in Chicago.

Fatima Cardoso, M.D., from the Champalimaud Foundation in Lisbon, Portugal, and colleagues performed a phase 3 trial involving women aged 18 to 70 years with moderate-to-severe vasomotor symptoms associated with endocrine therapy for HR-positive breast cancer or its prevention.

Women were randomly assigned to receive once-daily elinzanetant at a dose of 120 mg for 52 weeks or once-daily placebo for 12 weeks followed by once-daily elinzanetant at a dose of 120 mg for 40 weeks (316 and 158 patients, respectively). Only one of the patients was taking endocrine therapy for breast cancer prevention.

The researchers found that the mean change from baseline in the mean daily frequency of moderate-to-severe vasomotor symptoms at week 4 was −6.5 and −3.0 episodes for those receiving elinzanetant and placebo, respectively (least-squares mean difference, −3.5 episodes). The mean change was −7.8 and −4.2 episodes among those receiving elinzanetant and placebo, respectively, at week 12 (least-squares mean difference, −3.4 episodes).

Overall, 69.8% and 62.0% of those receiving elinzanetant and placebo, respectively, reported at least one adverse event during weeks 1 through 12; serious adverse events occurred in 2.5% and 0.6%, respectively.

“In a finding consistent with the results of previous trials involving postmenopausal women, treatment with elinzanetant resulted in significant decreases in the frequency of vasomotor symptoms and in sleep disturbances and improvements in health-related quality of life among women with moderate-to-severe vasomotor symptoms taking endocrine therapy for breast cancer,” the authors write.

Several authors disclosed ties to Bayer, which is developing elinzanetant and funded the study.

Copyright © 2025 HealthDay. All rights reserved.