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Imlunestrant

DRUG8 trials

Sponsors

Eli Lilly and Company, Jonsson Comprehensive Cancer Center

Conditions

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Breast CancerBreast NeoplasmsHealthyHepatic InsufficiencyInvasive Breast Carcinoma

Phase 1

A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors
Active, not recruitingNCT05307705
Eli Lilly and CompanyBreast Cancer
Start: 2022-05-11End: 2026-12-01Updated: 2026-03-27
A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function
CompletedNCT05440344
Eli Lilly and CompanyHealthy, Hepatic Insufficiency
Start: 2022-07-05End: 2024-02-28Updated: 2025-11-12
A Study of Imlunestrant (LY3484356) in Female Healthy Participants
CompletedNCT05444556
Eli Lilly and CompanyHealthy
Start: 2022-07-07End: 2022-11-02Updated: 2025-12-12
A Study of Imlunestrant (LY3484356) in Healthy Women
CompletedNCT05509816
Eli Lilly and CompanyHealthy
Start: 2022-09-12End: 2022-11-30Updated: 2025-11-12

Phase 2

Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Residual Disease, MIRI Trial
Not yet recruitingNCT07191717
Jonsson Comprehensive Cancer CenterAnatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8 +3
Start: 2026-04-30End: 2031-04-30Target: 42Updated: 2025-11-10
A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer
Not yet recruitingNCT07287098
Eli Lilly and CompanyBreast Neoplasms
Start: 2026-05-01End: 2029-12-01Target: 600Updated: 2026-03-27

Phase 3

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer
Active, not recruitingNCT04975308
Eli Lilly and CompanyBreast Neoplasms, Neoplasm Metastasis
Start: 2021-10-04End: 2027-08-31Updated: 2025-07-11
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
Active, not recruitingNCT05514054
Eli Lilly and CompanyBreast Neoplasms
Start: 2022-10-04End: 2032-03-01Target: 8000Updated: 2026-04-02

Related Papers

Abstract PS2-02-14: Improving Identification and Enrollment in HR+/HER2− Breast Cancer Trials Using AI Clinical Trial Patient Matching Tool
Clinical Cancer Research2026-02-17
Abstract GS1-01: Imlunestrant, an Oral Selective Estrogen Receptor Degrader (SERD), as Monotherapy & Combined with Abemaciclib, for Patients with ER+, HER2- Advanced Breast Cancer (ABC), Pretreated with Endocrine Therapy (ET): Results of the Phase 3 EMBER-3 trial
Clinical Cancer Research2025-06-131 citations
Abstract PS7-03: A first-in-human phase 1a/b trial of LOXO-783, a potent, highly mutant-selective, brain-penetrant, allosteric PI3Kα H1047R inhibitor in PIK3CA H1047R-mutant advanced breast cancer and other solid tumors: Results from the PIKASSO-01 study
Clinical Cancer Research2025-06-131 citations
Patient-reported outcomes (PROs) in patients with ER+, HER2- advanced breast cancer (ABC) treated with imlunestrant, investigator’s choice standard endocrine therapy, or imlunestrant + abemaciclib: Results from the phase III EMBER-3 trial.
Journal of Clinical Oncology2025-05-284 citations
Imlunestrant with or without abemaciclib in advanced breast cancer (ABC): Safety analyses from the phase III EMBER-3 trial.
Journal of Clinical Oncology2025-05-282 citations
Abstract 5977: Identification and characterization of an allosteric and mutant-selective PI3Kα inhibitor
Cancer Research2025-04-21
Imlunestrant with or without Abemaciclib in Advanced Breast Cancer
New England Journal of Medicine2024-12-11103 citations
The FACT-GP5 as a global tolerability measure: responsiveness and robustness to missing assessments.
2024-07-243 citations
Using an AI trial screening tool to assess language as a barrier for enrollment of underrepresented minorities in cancer clinical trials.
Journal of Clinical Oncology2024-05-29
heredERA Breast Cancer: a phase III, randomized, open-label study evaluating the efficacy and safety of giredestrant plus the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with previously untreated HER2-positive, estrogen receptor-positive locally advanced or metastatic breast cancer
BMC Cancer2024-05-246 citations
Abstract PS15-09: Imlunestrant monotherapy and in combination with abemaciclib, with or without an aromatase inhibitor, in estrogen receptor-positive (ER+), HER2-negative (HER2-) advanced breast cancer (aBC): updated results from the EMBER study
Cancer Research2024-05-022 citations
Abstract PD13-12: PD13-12 Imlunestrant, an oral selective estrogen receptor degrader, in combination with abemaciclib with or without an aromatase inhibitor, in estrogen receptor-positive advanced breast cancer: Results from the phase 1a/b EMBER study
Cancer Research2023-03-0111 citations
Abstract P4-08-02: LOXO-783: A potent, highly mutant selective and brain-penetrant allosteric PI3Kα H1047R inhibitor in combination with standard of care (SOC) treatments in preclinical PI3Kα H1047R-mutant breast cancer models
Cancer Research2023-03-019 citations
Abstract OT3-08-01: A phase 1 trial of LOXO-783, a potent, highly mutant-selective, brain-penetrant allosteric PI3Kα H1047R inhibitor in PIK3CA H1047R-mutant advanced breast cancer (aBC) and other solid tumors (PIKASSO-01, trial in progress)
Cancer Research2023-03-018 citations