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STML-ELA-0422

A study of elacestrant versus standard endocrine therapy in women and men with er+,her2-, early breast cancer with high risk of recurrence
Source : Import from center

clinicaltrials.gov reference: NCT06492616
ELEGANT
Breast Cancer Stage II
Breast Cancer Stage III
Breast Cancer Female
Breast Cancer
Male
High-Risk Breast Cancer
High Risk Breast Carcinoma
ER-positive Breast Cancer
ER-positive HER-2 Negative Breast Cancer
ER Positive/HER2 Low Breast Cancer
ER+
HER2-
Adjuvant
Adjuvant Therapy
Source : Import from center
Early
ER/PR
Her2/neu
cfNA
Recruiment open
Last modification : 2025/11/02
Study type

Interventional

Experimental drug

PHASE3


Target population

Medical condition (targeted specialty)

Therapeutic area choices

Cancer stages

Early

Biomarker

ER/PR

Her2/neu

Other

cfNA

Source : Import from center

Participants profils

Participants gender(s)

ALL

Source : Import from center
Subjects aptitude

Selection criterias

Inclusion criteria

Key Inclusion Criteria:

* Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry \[IHC\]), HER2-negative \[IHC = 0 or 1, or (IHC = 2 and in situ hybridization \[ISH\]-negative)\] on tumor biopsy or final surgical pathology specimen early stage resected invasive breast cancer without evidence of recurrence or distant metastases, per local laboratory, according to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
* Participants considered at high risk of recurrence at initial staging
* Participants who have received at least 24 months but not more than 60 months of endocrine therapy (AIs or tamoxifen) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i)
* Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor must have already completed or discontinued these treatments.

Key Exclusion Criteria:

* Participants with inflammatory breast cancer
* History of any prior (ipsilateral and/or contralateral) invasive breast cancer
* Participant with history of malignancy within 3 years of the date of randomization, except for adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
* Participants who have had more than a 6-month continuous interruption of prior SoC adjuvant endocrine therapy or who discontinued adjuvant endocrine therapy more than 6 months prior to randomization

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Source : Import from center
Exclusion criteria

Participants atteints d'un cancer du sein inflammatoire,
Participants atteints d'un cancer du sein métastatique de stade IV,
Participant ayant des antécédents de malignité dans les 3 ans suivant la date de randomisation, sauf
pour les cancers basocellulaire ou épidermoïde de la peau traité adéquatement, un cancer superficiel de la vessie ou un
carcinome in situ du col de l'utérus

Source : Import from center

Proposed Therapy or Intervention

Cohorts
Name Medical condition Treatment Recruitment status
Elacestrant Participants will receive 345 milligrams (mg) elacestrant once daily (QD) for 5 years. Data not available
  • Unknown
  • Standard of Care (SoC) Endocrine Therapy Participants will receive the SoC endocrine therapy that was used prior to randomization: * AI (anastrozole 1 mg QD, letrozole 2.5 mg QD, or exemestane 25 mg QD); or * Tamoxifen 20 mg QD Data not available
  • Unknown
  • Elacestrant
    Recruitment status
    unknown
    Standard of Care (SoC) Endocrine Therapy
    Recruitment status
    unknown
    Current data since : November 02, 2025 19:00

    Study description

    Study summary

    The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.

    Source : Import from center

    Locations

    Participating centers

      10 shown out of 442 centers
    • 'KLINIKUM ESSLINGEN GMBH

      Esslingen am neckar

      ESSLINGEN A.N., GERMANY

      Local recruitment
      Recruiting status: OPEN
      Local project contacts
      researchers:
    • 'SCHWERPUNKTPRAXIS FUER GYNAEKOLOGIE UND ONKOLOGIE

      Brandenburg

      FUERSTENWALDE /SPREE, GERMANY

      Local recruitment
      Recruiting status: OPEN
      Local project contacts
      researchers:
    • 2760168 - KLINIKUM FRANKFURT HÖCHST GMBH

      Frankfurt am main

      HESSE, GERMANY

      Local recruitment
      Recruiting status: OPEN
      Local project contacts
      researchers:
    • CENTRE HOSPITALIER UNIVERSITAIRE DE QUÉBEC *

      Québec

      QUÉBEC, CANADA

      Local recruitment
      Recruiting status: OPEN
      Contact details for recruitment
      Local project contacts
      researchers:
      • É. Poirier

      click here for more information about this center
      Cohorts
      Centre hospitalier Universitaire de Québec
      Data not available
      Current data since : July 31, 2025 00:22
    • CENTRE INTÉGRÉ DE SANTÉ ET DE SERVICES SOCIAUX DE LANAUDIÈRE *

      Joliette

      QUÉBEC, CANADA

      Local recruitment
      Recruiting status: OPEN
      Local project contacts
      researchers:
      • É. Martel

      co-researchers:
      • D. Morency

      • A. Brunot

      click here for more information about this center
      Cohorts
      Centre intégré de santé et de services sociaux de Lanaudière
      Data not available
      Current data since : November 04, 2025 00:20
    • CENTRE INTÉGRÉ DE SANTÉ ET DE SERVICES SOCIAUX DES LAURENTIDES *

      Saint-jérôme

      QUEBEC, CANADA

      Local recruitment
      Recruiting status: OPEN
      Contact details for recruitment
      Local project contacts
      researchers:
      • G. Cournoyer

      co-researchers:
      • C. Béland

      • M. Charron

      • M. Lessard

      • S. Venne

      • C. Jolivet

      • V. Morin

      • C. Melendez Pena

      click here for more information about this center
      Cohorts
      Centre intégré de santé et de services sociaux des Laurentides
      Data not available
      Current data since : December 04, 2025 00:21
    • CENTRE INTÉGRÉ UNIVERSITAIRE DE SANTÉ ET DE SERVICES SOCIAUX DU CENTRE-OUEST-DE-L’ÎLE-DE-MONTRÉAL *

      Montréal

      QUÉBEC, CANADA

      Local recruitment
      Recruiting status: OPEN
      Contact details for recruitment
      Data not available
      Local project contacts
      researchers:
      • J. Boileau

      click here for more information about this center
      Cohorts
      Centre intégré universitaire de santé et de services sociaux du Centre-Ouest-de-l’Île-de-Montréal
      Data not available
      Current data since : November 06, 2025 00:21
    • A.C.CAMARGO CANCER CENTER

      São paulo

      SP, BRAZIL

      Local recruitment
      Recruiting status: OPEN
      Local project contacts
      researchers:
    • ACRC/ARIZONA CLINICAL RESEARCH CENTER, INC.

      Tucson

      ARIZONA, UNITED STATES

      Local recruitment
      Recruiting status: OPEN
      Local project contacts
      researchers:
    • ADNAN MENDERES UNIVERSITESI - UYGULAMA VE ARASTIRMA HASTANESI

      Aydin

      TURKEY (TÜRKIYE)

      Local recruitment
      Recruiting status: OPEN
      Local project contacts
      researchers:

    Last modification : November 02, 2025
    Current data since : 26 Nov 14:03
    Data source : clinicaltrials.gov, Nagano
    Nagano reference: MP-28-2025-267
    clinicaltrials.gov reference: NCT06492616