本研究的主要目的是評估elacestrant與標準內分泌治療在節點陽性、雌激素受體陽性（ ER + ）、人表皮生長因子-2陰性（ HER2- ）早期乳癌高復發風險參與者中的有效性。
適應症：Breast Cancer
收案條件
納入條件
- 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:
- ≥4 positive axillary lymph nodes or
- positive axillary lymph nodes and
- Histologic grade 3 disease and/or
- Tumor size ≥5 centimeters and/or
- 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.
排除條件
- 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.
收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。