A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer
3상
진행 중(모집 완료)
NCT04975308
| 대상 질환 | Breast Neoplasms, Neoplasm Metastasis |
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| 임상 단계 | 3상 |
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| 스폰서 | Eli Lilly and Company |
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| 상태 | 진행 중(모집 완료) |
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| 참여자 수 | 874 명 |
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| 중재(약물) | Imlunestrant, Exemestane, Fulvestrant, Abemaciclib |
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| 시작일 | 2021년 10월 4일 |
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| 완료일 | 2024년 6월 24일 |
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| 결과 공개일 | 2025년 7월 11일 |
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요약
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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BENITIONS에서 보기
ClinicalTrials.gov 원문 보기
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