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 (ELEGANT)
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
III
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
The Johns Hopkins Hospital
1800 Orleans St Baltimore, MD 21287
Johns Hopkins at Greenspring Station
10755 Falls Road Timonium, MD 21093
Sibley Memorial Hospital
5255 Loughboro Road, N.W., Washington, D.C., 20016
Keywords
Contact Us
(410) 955-8964Brief Summary
Despite optimized adjuvant treatments for patients with high-risk ER+ HER2- breast cancer, patients continue to experience local and distant recurrences and new therapies are warranted. As elacestrant significantly prolonged progression-free survival (PFS) in the metastatic setting relative to endocrine monotherapy, with more pronounced activity in patients with endocrine sensitive tumors, it is hypothesized that elacestrant should prolong invasive breast cancer-free survival (IBCFS) in the earlier adjuvant setting, among patients who received prior adjuvant endocrine therapy with or without a cyclin-dependent kinase targeting enzymes CDK4 and CDK6 inhibitor (CDK4/6i).
Eligibility
Principal Inclusion Criteria:
- Histopathologically or cytologically confirmed ER-positive (>/= 10% by immunohistochemistry [IHC]), HER2 negative [IHC=0 or 1, or (IHC=2 and 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.
- Patients considered at high risk of recurrence defined, at initial staging, as: a) >/= 4 positive axillary lymph nodes or b) 1-3 positive axillary lymph nodes with either histologic grade 3 disease or tumor size >/= 5 cm.
- Patient has received at least 24 months but not more than 60 months of endocrine therapy (AIs or tamoxifen) with or without a CDK4/6i and with or without a luteinizing hormone-releasing hormone (LHRH) agonist.
- Female patients may be either postmenopausal, premenopausal, or perimenopausal.