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
Stemline Therapeutics, Inc.
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 lea…
Interventions
- DrugElacestrant
Administered as oral tablets
- DrugAnastrozole
Administered as oral tablets
- DrugLetrozole
Administered as oral tablets
- DrugExemestane
Administered as oral tablets
- DrugTamoxifen
Administered as oral tablets
Locations (536)
- Southern Cancer Center, PCDaphne, Alabama
- Ironwood Cancer and Research CentersChandler, Arizona
- Banner MD Anderson Cancer CenterGilbert, Arizona
- Mayo ClinicScottsdale, Arizona
- Arizona Clinical Research Center, Inc.Tucson, Arizona
- University of Arizona Cancer CenterTucson, Arizona