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
Interventional
Phase 3
Stemline Therapeutics, Inc. (Voir sur ClinicalTrials)
septembre 2024
octobre 2032
28 mai 2026
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 ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Alessandro Adriano VIANSONE | 19/06/2026 11:05:06 | Contacter | ||
Critères
Tous
- 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.