A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer
Phase 3
Active, not recruiting
NCT04975308
| Condition | Breast Neoplasms, Neoplasm Metastasis |
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| Phase | Phase 3 |
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| Sponsor | Eli Lilly and Company |
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| Status | Active, not recruiting |
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| Enrollment | 874 participants |
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| Interventions | Imlunestrant, Exemestane, Fulvestrant, Abemaciclib |
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| Start date | Oct 4, 2021 |
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| Completion date | Jun 24, 2024 |
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| Results posted | Jul 11, 2025 |
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Summary
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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Open in BENITIONS
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