BENITIONSClinical Trial Intelligence

A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer

3期 进行中(已停止招募) NCT05587296

适应症Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer, Hot Flashes
分期3期
申办方Bayer
状态进行中(已停止招募)
受试者人数474 人
干预(药物)Elinzanetant (BAY3427080)
开始日期2022年10月14日
完成日期2024年1月29日
结果公布日2025年10月29日

摘要

Researchers are looking for a better way to treat women with, or at high risk for developing hormone-receptor positive breast cancer, who have vasomotor symptoms (VMS), a condition of having hot flashes caused by anti-cancer therapy. VMS, also called hot flashes, are very common medical problems in women with hormone-receptor (HR)-positive breast cancer, who are receiving anti-cancer therapy. HR-positive breast cancer is a type of breast cancer, which has hormone-receptors (proteins) for female sex hormones estrogen and/or progesterone. These hormone-receptors may attach to hormones like estrogen and progesterone and thereby help cancer cells to grow and to spread. Treatments that stop these hormones from attaching to these receptors are currently used to slow or stop the growth of HR-positive breast cancer. It is already known that women with HR-positive breast cancer benefit from this treatment. However, hot flashes are common medical problems related to this therapy. They negatively affect quality of life of many women and may lead to discontinuation (stopping) of this therapy. The study treatment, elinzanetant is being developed to treat hot flushes. It works by blocking a subs

Mean Change in Frequency of Moderate to Severe Hot Flashes (HF) From Baseline to Week 4 (Assessed by Hot Flash Daily Diary [HFDD])

Baseline to Week 4 · hot flashes per day

Elinzanetant (BAY3427080)11.41 ± 6.89 hot flashes per day
Placebo - Elinzanetant (BAY3427080)11.52 ± 6.43 hot flashes per day
Elinzanetant (BAY3427080)-6.51 ± 6.13 hot flashes per day
Placebo - Elinzanetant (BAY3427080)-3.04 ± 5.04 hot flashes per day
p-value<0.0001
Diffrence in Least Squares (LS) means-3.48

Mean Change in Frequency of Moderate to Severe HFs From Baseline to Week 12 (Assessed by HFDD)

Baseline to Week 12 · hot flashes per day

Elinzanetant (BAY3427080)11.41 ± 6.89 hot flashes per day
Placebo - Elinzanetant (BAY3427080)11.52 ± 6.43 hot flashes per day
Elinzanetant (BAY3427080)-7.76 ± 6.17 hot flashes per day
Placebo - Elinzanetant (BAY3427080)-4.20 ± 6.06 hot flashes per day
p-value<0.0001
Difference in Least Squares Means-3.38

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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。