Title
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)

Description
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

Objective
Primary Objective:
1. 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.

Key Secondary Objectives:
1. Evaluate the efficacy of elacestrant relative to standard of care (SoC) in terms of distant relapse-free survival (DRFS).
2. Evaluate the efficacy of elacestrant relative to SoC in terms of overall survival (OS).

Secondary Objectives:
1. Evaluate the efficacy of elacestrant relative to SoC in terms of invasive disease-free survival (IDFS).
2. Characterize the safety of elacestrant in the trial patient population.
3. Evaluate the effect of elacestrant relative to SoC on patient-reported outcomes (PROs).
4. Characterize elacestrant steady-state pharmacokinetics (PK) and exposure-response relationships (efficacy and safety) in a subset of participants enrolled in the elacestrant arm at United States (US) clinical sites.

Treatment 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 Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.

Key Eligibility Key Inclusion Criteria:

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.

Applicable Disease Sites
Breast

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital