A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer
第3相
実施中（募集終了）
NCT04975308
| 対象疾患 | Breast Neoplasms, Neoplasm Metastasis |
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| 相 | 第3相 |
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| スポンサー | Eli Lilly and Company |
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| ステータス | 実施中（募集終了） |
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| 参加者数 | 874 名 |
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| 介入（薬剤） | Imlunestrant, Exemestane, Fulvestrant, Abemaciclib |
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| 開始日 | 2021年10月4日 |
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| 完了日 | 2024年6月24日 |
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| 結果公開日 | 2025年7月11日 |
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概要
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.
Investigator-assessed Progression Free Survival (PFS) (Between Arm A and Arm B)
Randomization to the date of first documented progression of disease or death from any cause (up to 28 months) · Months
| Arm A: Imlunestrant | 5.55 Months |
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| Arm B: Investigator's Choice of Endocrine Therapy | 5.52 Months |
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| p-value | 0.1158 |
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| Hazard Ratio (HR) | 0.867 (95% CI 0.724–1.039) |
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Investigator-assessed PFS (Between Arm C and Arm A)
Randomization to the date of first documented progression of disease or death from any cause (up to 26 months) · Months
| Arm C: Imlunestrant + Abemaciclib | 9.36 Months |
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| Arm A: Imlunestrant | 5.49 Months |
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| p-value | <0.0001 |
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| Hazard Ratio (HR) | 0.569 (95% CI 0.441–0.733) |
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Investigator-assessed PFS in the Estrogen Receptor 1 (ESR1)-Mutation Detected Population (Between Arm A and Arm B)
Randomization to the date of first documented progression of disease or death from any cause (up to 28 months) · Months
| Arm A: Imlunestrant | 5.49 Months |
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| Arm B: Investigator's Choice of Endocrine Therapy | 3.84 Months |
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| p-value | 0.0008 |
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| Hazard Ratio (HR) | 0.617 (95% CI 0.464–0.821) |
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BENITIONS で見る
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