Informations générales (source: ClinicalTrials.gov)
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 (ELEGANT)
Interventional
Phase 3
Stemline Therapeutics, Inc. (Voir sur ClinicalTrials)
septembre 2024
octobre 2032
08 août 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Tenon | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier De Pau - 64046 - Pau Cedex - Pyrénées-Atlantiques - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Regional et Universitaire (CHRU) de Besancon - L'Hopital Jean Minjoz - 25000 - Besancon - Alpes-Maritimes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire De Poitiers - Pôle Régional de Cancérologie - 86000 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| CHI De Fréjus / Saint-Raphael - 83600 - Fréjus - Var - France | Contact (sur clinicalTrials) | ||||
| CHU Amiens - Picardie Site Sud - 80000 - Amiens - Somme - France | Contact (sur clinicalTrials) | ||||
| CRLCC Jean Godinot - 51100 - Reims - Marne - France | Contact (sur clinicalTrials) | ||||
| Ct Oncologie Radiotherapie CORT 37 - 37170 - Chambray-lès-Tours - Indre-et-Loire - France | Contact (sur clinicalTrials) | ||||
| Hopital Universitaire Dupuytren - 87000 - Limoges - Limousin - France | Contact (sur clinicalTrials) | ||||
| ICONE - 51430 - Bezannes - Marne - France | Contact (sur clinicalTrials) | ||||
| Inst Cancerologie Strasbourg Europe - 67200 - Strasbourg - Alsace - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie Bourgogne - 21000 - Dijon - Saône-et-Loire - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de Lorraine - 54511 - Vandœuvre-Lès-Nancy Cedex 03 - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancerologie de l'Ouest - Oncology - 44805 - St. Herblain - Loire-Atlantique - France | Contact (sur clinicalTrials) | ||||
| Institut Sainte Catherine - 84000 - Avignon - Vaucluse - France | Contact (sur clinicalTrials) | ||||
| Polyclinique de Blois - 41260 - La Chaussée-Saint-Victor - Loir-et-Cher - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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.