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)

Sponsor:

Stemline Therapeutics, Inc

Sponsor Study ID:

STML-ELA-0422

CTO #:

104093

NCT Number:

NCT06492616

Phase:

III

Protocol Type:

Treatment

Age Group:

Adults

Disease Sites:

Breast

Study Objectives:

Evaluate the efficacy of elacestrant relative to standard endocrine therapy in terms of IBCFS in participants with node-positive, estrogen receptor-positive, HER2-negative early breast cancer with high risk of recurrence. Evaluate the efficacy of elacestrant relative to standard of care (SoC) in terms of distant relapse-free survival (DRFS). Evaluate the efficacy of elacestrant relative to SoC in terms of overall survival (OS).

eConsent:

Not available

Study Documents:

Open Study Documents
(MUSC NetID required for document access)