Imlunestrant

DRUG11 trials

Sponsors

Eli Lilly and Company, Jonsson Comprehensive Cancer Center, Dana-Farber Cancer Institute, Prelude Therapeutics Incorporated

Conditions

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Breast CancerBreast NeoplasmsEndometrial CancerHER2-negative Breast CancerHR+/HER2- Breast Cancer

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: 2026-12-01Target: 260Updated: 2026-10-14

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

First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

RecruitingNCT05768139

Eli Lilly and CompanyBreast Cancer, Solid Tumors, Adult

Start: 2023-04-17End: 2030-07-01Target: 880Updated: 2026-07-07

A Phase 1/1b Study of PRT13722 in Participants With Advanced HR+/HER2- Breast Cancer

Not yet recruitingNCT07905001

Prelude Therapeutics IncorporatedBreast Cancer, HER2-negative Breast Cancer, Hormone-receptor-positive Breast Cancer +4

Start: 2026-10-30End: 2029-10-31Target: 242Updated: 2026-10-29

Phase 2

Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Residual Disease, MIRI Trial

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: 2026-05-18End: 2031-04-30Target: 42Updated: 2026-08-20

A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer

RecruitingNCT07287098

Eli Lilly and CompanyBreast Neoplasms

Start: 2026-05-13End: 2029-12-01Target: 600Updated: 2026-10-08

Imlunestrant/Abemaciclib/Selinexor in Ovarian and Endometrial

Not yet recruitingNCT07832227

Dana-Farber Cancer InstituteEndometrial Cancer, Low Grade Ovarian Serous Adenocarcinoma

Start: 2026-12-01End: 2029-08-01Target: 60Updated: 2026-09-21

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: 2027-08-01Updated: 2026-07-22

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

A phase 1/2 trial of tersolisib (LY4064809/STX-478), a pan-mutant-selective PI3Kα inhibitor (PI3Kαi), in <i>PIK3CA</i> -mutant advanced solid tumors: Updated results from PIKALO-1.

Journal of Clinical Oncology2026-05-27

Imlunestrant with or without abemaciclib in advanced breast cancer: safety analyses from the EMBER-3 trial

npj Breast Cancer2026-04-27

Abstract PS1-08-24: A phase 1/2 trial of LY4064809 (STX-478), a pan-mutant-selective PI3Kα inhibitor in HR+, HER2- advanced breast cancer (ABC): Updated results from PIKALO-1

Clinical Cancer Research2026-02-17

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 PO1-20-04: STX-478-101: A phase 1/2, first-in-human study of STX-478 monotherapy or in combination with fulvestrant in patients with breast cancer or other advanced solid tumors (trial in progress)

Cancer Research2024-05-02

Abstract PO2-18-04: STX-478 is a potentially best-in-class mutant-selective PI3Kα inhibitor that demonstrates robust efficacy in ER+ breast cancer models as monotherapy and in combination with standard of care agents

Cancer Research2024-05-02

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