Status:
RECRUITING
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
Lead Sponsor:
Stemline Therapeutics, Inc.
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 G...
Eligibility Criteria
Inclusion
- Key
- Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry \[IHC\]), HER2-negative \[IHC = 0 or 1, or (IHC = 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
- 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
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
September 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2032
Estimated Enrollment :
4220 Patients enrolled
Trial Details
Trial ID
NCT06492616
Start Date
September 27 2024
End Date
October 1 2032
Last Update
December 24 2025
Active Locations (505)
Enter a location and click search to find clinical trials sorted by distance.
1
Southern Cancer Center, PC
Daphne, Alabama, United States, 36526
2
Ironwood Cancer and Research Centers
Chandler, Arizona, United States, 85224
3
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234-2165
4
Mayo Clinic
Scottsdale, Arizona, United States, 85259-5452