New Study Explores Treatment for Hot Flashes in Women with HR-Positive Breast Cancer

Researchers are conducting a clinical trial to find a better treatment for women with, or at high risk for developing hormone-receptor positive (HR-positive) breast cancer, who experience vasomotor symptoms (VMS), commonly known as hot flashes, due to anti-cancer therapy. HR-positive breast cancer is characterized by the presence of hormone-receptors for estrogen and/or progesterone, which can promote cancer growth. Current treatments aim to block these hormones from attaching to the receptors, slowing or stopping cancer progression. However, these therapies often lead to hot flashes, significantly affecting the quality of life and potentially causing discontinuation of treatment.

The study focuses on elinzanetant, a treatment under development that works by blocking neurokinin, a substance believed to trigger hot flashes. The primary goal is to assess elinzanetant's effectiveness in reducing the number and severity of hot flashes compared to a placebo over 4 and 12 weeks. Additionally, the study will evaluate the safety of elinzanetant by monitoring adverse events among participants.

Participants will be randomly assigned to two groups: one receiving elinzanetant and the other starting with a placebo before switching to elinzanetant after 12 weeks. All participants will continue their existing anti-cancer therapy throughout the study. The trial involves recording hot flash symptoms, answering quality of life questionnaires, and undergoing health assessments, including blood and urine tests, ECGs, transvaginal ultrasounds, mammograms, and cervical cytology tests. The study spans approximately 62 weeks, with the possibility of extending treatment for an additional 2 years for those who complete the initial 52-week treatment phase.

This research represents a significant step towards improving the management of hot flashes in women undergoing treatment for HR-positive breast cancer, potentially enhancing their quality of life and adherence to anti-cancer therapy.