^
    8d
    EMBER-4: A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer (clinicaltrials.gov)
    P3, N=8000, Active, not recruiting, Eli Lilly and Company | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    tamoxifen • letrozole • anastrozole • exemestane • Inluriyo (imlunestrant)
    16d
    PIKASSO-01: A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors (clinicaltrials.gov)
    P1, N=193, Active, not recruiting, Eli Lilly and Company | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    paclitaxel • Verzenio (abemaciclib) • fulvestrant • letrozole • anastrozole • exemestane • Inluriyo (imlunestrant) • LOXO-783
    22d
    PreEMBER: A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer (clinicaltrials.gov)
    P2, N=600, Not yet recruiting, Eli Lilly and Company | Trial completion date: Jan 2029 --> Dec 2029
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    tamoxifen • Inluriyo (imlunestrant) • goserelin acetate
    2ms
    PreEMBER: A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer (clinicaltrials.gov)
    P2, N=600, Not yet recruiting, Eli Lilly and Company
    New P2 trial
    |
    tamoxifen • Inluriyo (imlunestrant) • goserelin acetate
    2ms
    Imlunestrant with or without Abemaciclib in Advanced Breast Cancer: Updated Efficacy Results from the phase 3 EMBER-3 trial. (PubMed, Ann Oncol)
    These findings reinforce the clinical benefit of imlunestrant-based regimens as a potential all-oral, chemotherapy-free treatment option for endocrine-pretreated patients with ER+, HER2-ABC.
    P3 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative • ESR1 mutation
    |
    Verzenio (abemaciclib) • fulvestrant • exemestane • Inluriyo (imlunestrant)
    2ms
    Imlunestrant: First Approval. (PubMed, Drugs)
    In September 2025, imlunestrant was approved for the treatment of adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy in the USA. This article summarizes the milestones in the development of imlunestrant leading to this first approval for use in patients with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative • HER-2 mutation • ESR1 mutation
    |
    Inluriyo (imlunestrant)
    3ms
    Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Residual Disease, MIRI Trial (clinicaltrials.gov)
    P2, N=42, Not yet recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Sep 2031 --> Apr 2031 | Initiation date: Sep 2025 --> Apr 2026 | Trial primary completion date: Sep 2030 --> Apr 2030
    Trial completion date • Trial initiation date • Trial primary completion date • Minimal residual disease
    |
    Verzenio (abemaciclib) • Inluriyo (imlunestrant)
    4ms
    Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Residual Disease, MIRI Trial (clinicaltrials.gov)
    P2, N=42, Not yet recruiting, Jonsson Comprehensive Cancer Center
    New P2 trial • Minimal residual disease
    |
    Verzenio (abemaciclib) • Inluriyo (imlunestrant)
    7ms
    PIKASSO-01: A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors (clinicaltrials.gov)
    P1, N=193, Active, not recruiting, Eli Lilly and Company | Trial primary completion date: May 2025 --> Dec 2025
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 negative • PIK3CA mutation
    |
    paclitaxel • Verzenio (abemaciclib) • fulvestrant • letrozole • anastrozole • exemestane • Inluriyo (imlunestrant) • LOXO-783
    8ms
    Disposition and Absolute Bioavailability of Oral Imlunestrant in Healthy Women: A Phase 1, Open-Label Study. (PubMed, Clin Pharmacol Drug Dev)
    Imlunestrant was well tolerated as an oral solution or as a tablet/intravenous dose. Eight participants reported mild/moderate treatment-related adverse events that resolved by the end of the study.
    P1 data • Journal
    |
    ER (Estrogen receptor)
    |
    ER positive
    |
    Inluriyo (imlunestrant)