^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners

    COMPANY:
    Menarini

    i
    Other names: Menarini | Stemline Therapeutics | A. Menarini Industrie Farmaceutiche Riunite S.r.l. | A. Menarini Philippines, Inc. | A.Menarini Asia-Pacific Holdings Pte Ltd | Berlin-Chemie AG Menarini Group | Berlin-Chemie Menarini | Menarini (Thailand) Limited | Menarini International Operations Luxembourg SA | Stemline Therapeutics, Inc. | Menarini Ricerche | Menarini Biotech | Menarini Diagnostics | Menarini | Silicon Biosystems | Menarini Group | Menarini Silicon Biosystems, Inc. | Stemline Therapeutics, Inc. | Stemline Therapeutics | Stemline Therapeutics, Inc | Stemline Therapeutics Inc | Stemline Therapeutics Inc. | Stemline
    Related tests:
    Evidence

    News

    2ms
    ELEGANT: Elacestrant versus standard endocrine therapy (ET) in women and men with node-positive, estrogen receptor–positive (ER+), HER2-negative (HER2−), early breast cancer (eBC) with high risk of recurrence in a global, multicenter, randomized, open-label phase 3 study. (ASCO 2026)
    P3 | " ELEGANT (NCT06492616) is a global, multicenter, open-label Ph3 study designed to evaluate elacestrant vs SOC ET (AI or tamoxifen) in patients with eBC and high risk of recurrence. Key secondary objectives are distant relapse-free survival, overall survival, invasive disease-free survival, safety, PROs-QoL, and PK. Planned enrollment is 4,220 patients; recruitment is ongoing."
    Clinical • P3 data
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    tamoxifen • Orserdu (elacestrant)
    2ms
    ADELA: A double-blind, placebo-controlled, randomized phase 3 trial of elacestrant (Ela) + everolimus (EVE) versus elacestrant + placebo in ER+/HER2− advanced breast cancer (aBC) patients with ESR1-mutated tumors progressing on endocrine therapy (ET) + CDK4/6i. (ASCO 2026)
    P1/2, P3 | "Pts will receive dexamethasone mouthwash during the first 8 weeks. Planned enrollment is 240 pts. Recruitment is ongoing across Spain, France, Greece, Italy, Germany, Austria, Czech Republic, United Kingdom, and Brazil."
    Clinical • P3 data
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CDK4 (Cyclin-dependent kinase 4)
    |
    everolimus • dexamethasone • Orserdu (elacestrant)
    3ms
    Elacestrant (Ela) in combination with everolimus (Eve) or abemaciclib (Abema) in patients with ER+/HER2- locally advanced or metastatic breast cancer mBC: phase 2 results from ELEVATE, an open-label, umbrella study (AACR 2026)
    "ELEVATE is evaluating Ela combined with Eve, alpelisib, capivasertib, Abema, ribociclib, or palbociclib to address resistance mechanisms. Ela combinations show a consistent clinically meaningful PFS irrespective of ESR1m status in pts with ER+/HER2- mBC after progressive disease on ET ± prior CDK4/6i, and could become an ET backbone for combination strategies, supporting an all-oral approach.NR, not reached *Maturity not reached for PFS (95% CI) for genomic subgroups (ESR1 / PIK3CA) or by prior CDK4/6i exposure."
    Clinical • P2 data • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CDK4 (Cyclin-dependent kinase 4)
    |
    Ibrance (palbociclib) • everolimus • Piqray (alpelisib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • Truqap (capivasertib) • Orserdu (elacestrant)
    3ms
    ADELA: A double-blind, placebo-controlled, randomized phase 3 trial of elacestrant (Ela) + everolimus (EVE) versus elacestrant + placebo in ER+/HER2- advanced breast cancer (aBC) patients with ESR1-mutated tumors progressing on endocrine therapy (ET) + CDK4/6i (AACR 2026)
    P1/2, P3 | "Secondary objectives are investigator-assessed OS, PFS, ORR, CBR, DoR, TTR, best percentage change in tumor burden, safety, HRQoL.Status: Planned enrollment is 240 pts. Recruitment is ongoing across Spain, France, Greece, Italy, Germany, Austria, Czech Republic, United Kingdom, and Brazil."
    Clinical • P3 data
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CDK4 (Cyclin-dependent kinase 4)
    |
    everolimus • Orserdu (elacestrant)
    3ms
    ELEGANT: Elacestrant versus standard endocrine therapy (ET) in women and men with node-positive, estrogen receptor-positive (ER+), HER2-negative (HER2-), early breast cancer (eBC) with high risk of recurrence in a global, multicenter, randomized, open-label phase 3 study (AACR 2026)
    P3 | "Given that elacestrant demonstrated efficacy in mBC regardless of ESR1m status relative to SOC ET and has shown biologic activity in eBC, it is hypothesized that elacestrant can prolong invasive breast cancer-free survival (IBCFS) in patients with high-risk eBC who received prior adjuvant ET±CDK4/6i.Design and ELEGANT (NCT06492616) is a global, multicenter, open-label Ph3 study designed to evaluate elacestrant vs SOC ET (AI or tamoxifen) in patients with eBC and high risk of recurrence. The primary objective is IBCFS. Key secondary objectives are distant relapse-free survival, overall survival, invasive disease-free survival, safety, PROs-QoL, and PK.Status: Planned enrollment is 4,220 patients; recruitment is ongoing."
    Clinical • P3 data
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    tamoxifen • Orserdu (elacestrant)
    4ms
    ELEGANT: Elacestrant (Ela) Versus Standard Endocrine Therapy (ET) in Patients (Pts) With Node-positive, Estrogen Receptor-positive (ER+), HER2-negative (HER2-), Early Breast Cancer (eBC) With High Risk of Recurrence in a Global, Multicenter, Randomized, Open-label Phase 3 Study (DKK 2026)
    P3 | "Design and ELEGANT (NCT06492616) is a global, multicenter, open-label phase 3 study evaluating Ela vs SOC ET (AI or tamoxifen) in pts with eBC and a high risk of recurrence. Key secondary endpoints are distant relapse-free survival, OS, invasive disease-free survival, safety, QoL PROs, and PK. Status: Planned enrollment is 4,220 pts; recruitment is ongoing."
    Clinical • P3 data
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    tamoxifen • Orserdu (elacestrant)
    7ms
    Current treatment strategies for patients with ER+/HER2 - metastatic breast cancer (DGHO 2025)
    "Sponsored by Menarini Stemline."
    Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    8ms
    ELEGANT: Elacestrant versus standard endocrine therapy in women and men with node-positive, estrogen receptor-positive, HER2-negative, early breast cancer with high risk of recurrence in a global, multicenter, randomized, open-label phase 3 study (JADPRO 2025)
    P3 | "- Elacestrant 345 mg once daily (QD) OR SOC ET that was used prior to randomization • Al (anastrozole 1 mg QD, letrozole 2.5 mg QD, or exemestane 25 mg QD); OR Tamoxifen 20 mg QD • A total of 4,220 patients will be randomized from approximately 500 sites across North America, South America, Europe, and Asia. • Elacestrant could offer a new class of medication in the adjuvant setting for patients with ER+/HER2- breast cancer with a high risk of recurrence. • The study is open for enrollment; dedicated efforts are underway to ensure racial and ethnic diversity and an inclusive group of participants"
    Clinical • P3 data
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CDK4 (Cyclin-dependent kinase 4)
    |
    Prosigna® Breast Risk of Recurrence (ROR) Test
    |
    tamoxifen • letrozole • anastrozole • exemestane • Orserdu (elacestrant)