Trial NCT06492616
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
- Phase
- Phase 3
- Sponsor
- Stemline Therapeutics, Inc.
- Conditions
- Breast Cancer
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Key Inclusion Criteria:
* 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:
1. ≥4 positive axillary lymph nodes or
2. 1-3 positive axillary lymph nodes and
1. Histologic grade 3 disease and/or
2. Tumor size ≥5 centimeters and/or
3. 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.
Key Exclusion Criteria:
* Participants with inflammatory breast cancer.
* History of any prior (ipsilateral and/or contralateral) invasive breast cancer.Prior malignancy
* 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Restrictions found (1)
- Prior malignancyOutrightexclusionShow in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County
- Boston Medical Center · Boston, Suffolk County
- Beth Israel Deaconess Medical Center · Boston, Suffolk County
- Dana Farber Cancer Institute · Boston, Suffolk County
- Mass General North Shore Cancer Center · Danvers, Essex County
- Dana Farber Cancer Institute at Foxborough · Foxborough, Norfolk County
- Dana Farber Cancer Institute - Merrimack Valley · Methuen, Essex County
- Dana-Farber Cancer Institute at Milford Regional · Milford, Worcester County
- Mass General Cancer Center at Newton-Wellesley Hospital's Vernon Cancer Center · Newton, Middlesex County
- Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital · South Weymouth, Norfolk County
- Mass General - North Shore Cancer Center · Waltham, Middlesex County