A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
Phase 3 – large-scale trial before approval
Conditions:
Breast Cancer
Sponsor: Stemline Therapeutics, Inc.
trial.available_in:
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Overview
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.
Who can participate
Key Inclusion Criteria:
* Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry \[IHC\]), HER2-negative \[IHC = 0, 1+, 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 are off current adjuvant endocrine therapy more than 6 months prior to randomization
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Interventions
Elacestrant
DRUG
Anastrozole
DRUG
Letrozole
DRUG
Exemestane
DRUG
Tamoxifen
DRUG
Locations
536
Argentina (11)
(COIBA)Centro de Oncologia e Investigacion Buenos Aires
Berazategui , Buenos Aires
Fundacion Respirar
Buenos Aires , Buenos Aires F.D.
Organizacion Medica de Investigacion (OMI)
Buenos Aires , Buenos Aires F.D.
Clinica Adventista Belgrano
Buenos Aires , Tucumán Province
Instituto Argentino de Diagnostico y Tratamiento
Buenos Aires
Centro de Investigación CIPREC
C.a.b.a. , Buenos Aires F.D.
Centro Oncológico Korben
CABA , Buenos Aires F.D.
Centro Medico Privado CEMAIC
Córdoba , Córdoba Province
Inst Med Fund Estudios Clinicos
Rosario , Santa Fe Province
Instituto de Oncologia de Rosario
Rosario , Santa Fe Province
Centro Oncologico de Excelencia
San Juan
Australia (25)
Cancer Research SA
Adelaide , South Australia
Royal Adelaide Hospital - Oncology
Adelaide , South Australia
Icon Cancer Centre Wesley
Auchenflower , Quuensland
Flinders Medical Centre
Bedford Park , South Australia
Box Hill Hospital
Box Hill , Victoria
Monash Medical Centre
Clayton , Victoria
St Vincent's Hospital Sydney
Darlinghurst , New South Wales
Northern Hospital
Epping , Victoria
Lake Macquarie Private Hospital - Oncology
Gateshead , New South Wales
Austin Health
Heidelberg
Icon Cancer Centre Hobart
Hobart
Icon Cancer Centre Townsville
Hyde Park , Queensland
St George Hospital - Medical Oncology
Kogarah , New South Wales
Icon Cancer Centre Kurralta Park
Kurralta Park , South Australia
Launceston General Hospital - Medical Oncology
Launceston , Tasmania
Lismore Base Hospital - Cancer Care , Haematology Unit
Lismore , New South Wales
Macquarie University
Macquarie Park , New South Wales
Maroondah Hospitals - Medical Oncology
Melbourne , Victoria
Breast Cancer Research Centre
Nedlands , Western Australia
Mater Hospital Sydney
North Sydney , New South Wales
Mid North Coast Cancer Institute
Port Macquarie
Goulburn Valley Health
Shepparton , Victoria
Icon Cancer Centre Southport
Southport , Queensland
Westmead Hospital
Westmead , New South Wales
The Queen Elizabeth Hospital
Woodville , South Australia
Austria (5)
Universitätsklinikum Krems
Krems , Lower Austria
LKH Hochsteiermark
Leoben , Styria
Universitatsklinikum St. Polten
Sankt Pölten , Lower Austria
Hanusch Krankenhaus
Vienna
Brustgesundheitszentrum Süd
Weiz , Styria
Belgium (12)
Edith Cavell Inter-regional Hospital Centre (CHIREC) - Delta Hospital
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