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 |
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| 分期 | 3期 |
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| 申办方 | Bayer |
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| 状态 | 进行中(已停止招募) |
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| 受试者人数 | 474 人 |
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| 干预(药物) | Elinzanetant (BAY3427080) |
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| 开始日期 | 2022年10月14日 |
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| 完成日期 | 2024年1月29日 |
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| 结果公布日 | 2025年10月29日 |
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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 |
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| Placebo - Elinzanetant (BAY3427080) | 11.52 ± 6.43 hot flashes per day |
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| Elinzanetant (BAY3427080) | -6.51 ± 6.13 hot flashes per day |
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| Placebo - Elinzanetant (BAY3427080) | -3.04 ± 5.04 hot flashes per day |
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| 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 |
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| Placebo - Elinzanetant (BAY3427080) | 11.52 ± 6.43 hot flashes per day |
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| Elinzanetant (BAY3427080) | -7.76 ± 6.17 hot flashes per day |
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| Placebo - Elinzanetant (BAY3427080) | -4.20 ± 6.06 hot flashes per day |
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| p-value | <0.0001 |
| Difference in Least Squares Means | -3.38 |
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