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.
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.
≥4 positive axillary lymph nodes or
1-3 positive axillary lymph nodes and
Histologic grade 3 disease and/or
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.
Parallel
Elacestrant
DrugAdministered as oral tablets
Anastrozole
DrugAdministered as oral tablets
Letrozole
DrugAdministered as oral tablets
Exemestane
DrugAdministered as oral tablets
Tamoxifen
DrugAdministered as oral tablets
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
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
Overall Survival (OS)
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
Number of Participants With Adverse Events (AEs)
Click on the lead sponsor to view all of their trials.
