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NCT06492616ClinicalTrials.gov

A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence

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-A Global, Multicenter, Randomized, Open-label Phase 3 Study

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En resumen

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.

Fase 34220 participantes buscados567 centros28 países

Categorías

Oncología63%Endocrino y metabólico22%Dermatología15%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2024-07-09; recorded start 2024-09-27
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 15 other studies in this databaseCounted from the lead sponsor named in the record (Stemline Therapeutics, Inc.)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourMODERATE

A moderately rigorous design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding0/20

    Open-label

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type10/10

    Mortality / MACE endpoint (hard clinical outcome)

  • Multi-centre8/8

    Multi-centre: 555 sites

  • Data monitoring committee0/7

    Data monitoring committee not stated in the record

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 4,220 participants (target), run at 567 sites, across 28 countries.

How this score is built
  • Enrolment35/40

    4,220 participants (target)

  • Site count25/25

    555 sites

  • Country count15/15

    28 countries

  • Planned duration10/10

    Planned over about 98 months

  • Sponsor scale3/10

    Stemline Therapeutics, Inc. has led 13 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

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.

Afecciones

  • Breast Cancer

Elegibilidad

SexoTodos
Edades18 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

Key Inclusion Criteria: * Histopathologically or cytologically confirmed ER+ (≥10% by immunohistochemistry \[IHC\]), HER2- (tumors with an IHC score of 0, 1+, or 2+ with in situ hybridization \[ISH\]-negative \[not amplified\]). ISH-negative without IHC testing will also be eligible 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/College of American Pathologists guidelines. * Participants must be node positive (microscopic and macroscopic tumor involvement are allowed) and fulfill one of the following criteria: 1. ≥4 positive axillary lymph nodes or 2. 1-3 positive axillary lymph nodes and 1. Histologic grade 3 disease and/or 2. Tumor size ≥5 centimeters and/or 3. High genomic risk (identified by Oncotype, MammaPrint, EndoPredict, PAM50) * Participants who are currently taking endocrine therapy (aromatase inhibitors or tamoxifen) and have received at least 24 months but not more than 60 months of endocrine therapy at the time of randomization (Cycle 1 Day 1 \[C1D1\]) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i) and with or without a luteinizing hormone-releasing hormone agonist. * Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase 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 non-breast 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 are off current adjuvant endocrine therapy more than 6 months prior to randomization. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoNONE (0)
Inscripción4220 participantes buscados

Patrocinador y colaboradores

  • Stemline Therapeutics, Inc. Patrocinador

Grupos e intervenciones

  • ElacestrantEXPERIMENTAL

    Participants will receive 345 milligrams (mg) elacestrant once daily (QD) for 5 years.

  • Standard of Care (SoC) Endocrine TherapyEXPERIMENTAL

    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

Intervenciones

  • Fármaco Anastrozole

    Administered as oral tablets

  • Fármaco Elacestrant

    Administered as oral tablets

  • Fármaco Exemestane

    Administered as oral tablets

  • Fármaco Letrozole

    Administered as oral tablets

  • Fármaco Tamoxifen

    Administered as oral tablets

Variables de resultado

  1. Variable de resultado principal

    Invasive Breast Cancer-Free Survival (IBCFS)

    Assessed by the time from date of randomization to the date of first occurrence of: * Ipsilateral invasive breast tumor recurrence * Local/regional invasive breast cancer recurrence * Distant recurrence * Contralateral invasive breast cancer, or * Death attributable to any cause

    Plazo Up to 5 years

  2. Variable de resultado secundaria

    Distant Relapse-Free Survival (DRFS)

    Assessed by the time from date of randomization to the date of first occurrence of: * Distant recurrence, or * Death attributable to any cause

    Plazo Up to 5 years

  3. Variable de resultado secundaria

    Overall Survival (OS)

    Plazo Up to 5 years

  4. Variable de resultado secundaria

    Invasive Disease-Free Survival (IDFS)

    Assessed by the time from date of randomization to the date of first occurrence of: * Local/regional recurrence * Contralateral recurrence * Second primary non-breast invasive cancer * Distant recurrence, or * Death attributable to any cause

    Plazo Up to 5 years

  5. Variable de resultado secundaria

    Number of Participants With Adverse Events (AEs)

    Plazo Up to 5 years plus 28 days

  6. Variable de resultado secundaria

    Change from Baseline in Global Health Status Quality of Life Scale score, as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    Plazo Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5

  7. Variable de resultado secundaria

    Change from Baseline in the Physical Functioning Sub-Scale Score as Assessed by EORTC QLQ-C30

    Plazo Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5

  8. Variable de resultado secundaria

    Change From Baseline in the Breast Cancer Endocrine Therapy Symptoms Sub-Scale Score, as Assessed by the EORTC Quality of Life Breast Cancer Questionnaire module (EORTC QLQ-BR42)

    Plazo Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5

  9. Variable de resultado secundaria

    Change From Baseline in Side Effects, as Assessed by the Question 168 of the European Organization for the Research and Treatment of Cancer Question Library (EORTC Q168)

    Plazo Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5

  10. Variable de resultado secundaria

    Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of Elacestrant

    Plazo Predose up to 4 hours postdose

  11. Variable de resultado secundaria

    Maximum Plasma Concentration at Steady State (Cmaxss) of Elacestrant

    Plazo Predose up to 4 hours postdose

Fechas

Fecha de inicio27 de septiembre de 2024 (real)
Finalización principal1 de agosto de 2029 (estimada)
Finalización1 de octubre de 2032 (estimada)
Primera publicación9 de julio de 2024 (real)
Última actualización15 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezseptiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

501 centros están en reclutamiento

Argentina

CentroCiudadEstado o regiónEstado
(COIBA)Centro de Oncologia e Investigacion Buenos AiresBerazateguiBuenos AiresEn reclutamiento
Clinica Adventista BelgranoBuenos AiresTucumán ProvinceEn reclutamiento
Fundacion RespirarBuenos AiresBuenos Aires F.D.En reclutamiento
Organizacion Medica de Investigacion (OMI)Buenos AiresBuenos Aires F.D.En reclutamiento
Instituto Argentino de Diagnostico y TratamientoBuenos AiresEn reclutamiento
Centro de Investigación CIPRECC.a.b.a.Buenos Aires F.D.En reclutamiento
Centro Oncológico KorbenCABABuenos Aires F.D.En reclutamiento
Centro Medico Privado CEMAICCórdobaCórdoba ProvinceEn reclutamiento
Inst Med Fund Estudios ClinicosRosarioSanta Fe ProvinceEn reclutamiento
Instituto de Oncologia de RosarioRosarioSanta Fe ProvinceEn reclutamiento
Centro Oncologico de ExcelenciaSan JuanEn reclutamiento

Australia

CentroCiudadEstado o regiónEstado
Cancer Research SAAdelaideSouth AustraliaEn reclutamiento
Royal Adelaide Hospital - OncologyAdelaideSouth AustraliaEn reclutamiento
Icon Cancer Centre WesleyAuchenflowerQueenslandEn reclutamiento
Flinders Medical CentreBedford ParkSouth AustraliaEn reclutamiento
Box Hill HospitalBox HillVictoriaEn reclutamiento
Monash Medical CentreClaytonVictoriaEn reclutamiento
St Vincent's Hospital SydneyDarlinghurstNew South WalesEn reclutamiento
Northern HospitalEppingVictoriaEn reclutamiento
Lake Macquarie Private Hospital - OncologyGatesheadNew South WalesEn reclutamiento
Austin HealthHeidelbergEn reclutamiento
Icon Cancer Centre HobartHobartEn reclutamiento
Icon Cancer Centre TownsvilleHyde ParkQueenslandEn reclutamiento
St George Hospital - Medical OncologyKogarahNew South WalesEn reclutamiento
Icon Cancer Centre Kurralta ParkKurralta ParkSouth AustraliaEn reclutamiento
Launceston General Hospital - Medical OncologyLauncestonTasmaniaEn reclutamiento
Lismore Base Hospital - Cancer Care , Haematology UnitLismoreNew South WalesEn reclutamiento
Macquarie UniversityMacquarie ParkNew South WalesEn reclutamiento
Maroondah Hospitals - Medical OncologyMelbourneVictoriaEn reclutamiento
Breast Cancer Research CentreNedlandsWestern AustraliaEn reclutamiento
Mater Hospital SydneyNorth SydneyNew South WalesEn reclutamiento
Mid North Coast Cancer InstitutePort MacquarieEn reclutamiento
Goulburn Valley HealthSheppartonVictoriaEn reclutamiento
Icon Cancer Centre SouthportSouthportQueenslandEn reclutamiento
Westmead HospitalWestmeadNew South WalesEn reclutamiento
The Queen Elizabeth HospitalWoodvilleSouth AustraliaEn reclutamiento

Austria

CentroCiudadEstado o regiónEstado
Medizinische Universität GrazGrazStyriaEn reclutamiento
Universitätsklinikum KremsKremsLower AustriaEn reclutamiento
LKH HochsteiermarkLeobenStyriaEn reclutamiento
Universitatsklinikum St. PoltenSankt PöltenLower AustriaEn reclutamiento
Hanusch KrankenhausViennaEn reclutamiento
Brustgesundheitszentrum SüdWeizStyriaEn reclutamiento

Belgium

CentroCiudadEstado o regiónEstado
Edith Cavell Inter-regional Hospital Centre (CHIREC) - Delta HospitalAalstBrussels CapitalEn reclutamiento
Algemeen Ziekenhuis KlinaBrasschaatAntwerpenEn reclutamiento
Association Hospitaliere De Bruxelles Et De Schaerbeek - Centre Hospitalier Universitaire BrugmannBrusselsBrussels CapitalEn reclutamiento
Institut Jules BordetBrusselsEn reclutamiento
CHU Saint-PierreBrusselsBrussels CapitalEn reclutamiento
Grand Hopital de Charleroi - Site Les ViviersCharleroiHainautEn reclutamiento
Jessa Ziekenhuis - Campus Virga Jesse - Medische OncologieHasseltLimburgEn reclutamiento
UZ LeuvenLeuvenVlaams BrabantEn reclutamiento

En el registro figuran 517 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 15 de septiembre de 2026

    Centro añadido

    5 sites added (567 total)

    562567

  2. 17 de agosto de 2026

    Centro añadido

    7 sites added (562 total)

    555562

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT06492616