Last updated 26 days ago
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
4220 patients around the world
Available in Spain, United States, Belgium, Argentina
Stemline Therapeutics, Inc.
1Research sites
4220Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry), HER2-negative (IHC = 0 or 1, or (IHC = 2 and in situ hybridization-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.
- 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.
Sites
Organización Médica de Investigación (OMI)
Recruiting
StudyELEGANT
SponsorStemline Therapeutics, Inc.
Study typeInterventional
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06492616
