A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer
3期
进行中（已停止招募）
NCT04975308
| 适应症 | Breast Neoplasms, Neoplasm Metastasis |
|---|
| 分期 | 3期 |
|---|
| 申办方 | Eli Lilly and Company |
|---|
| 状态 | 进行中（已停止招募） |
|---|
| 受试者人数 | 874 人 |
|---|
| 干预（药物） | Imlunestrant, Exemestane, Fulvestrant, Abemaciclib |
|---|
| 开始日期 | 2021年10月4日 |
|---|
| 完成日期 | 2024年6月24日 |
|---|
| 结果公布日 | 2025年7月11日 |
|---|
摘要
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 |
|---|
| Arm B: Investigator's Choice of Endocrine Therapy | 5.52 Months |
|---|
| p-value | 0.1158 |
|---|
| Hazard Ratio (HR) | 0.867 (95% CI 0.724–1.039) |
|---|
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 |
|---|
| Arm A: Imlunestrant | 5.49 Months |
|---|
| p-value | <0.0001 |
|---|
| Hazard Ratio (HR) | 0.569 (95% CI 0.441–0.733) |
|---|
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 |
|---|
| Arm B: Investigator's Choice of Endocrine Therapy | 3.84 Months |
|---|
| p-value | 0.0008 |
|---|
| Hazard Ratio (HR) | 0.617 (95% CI 0.464–0.821) |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
全部试验
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。