TPS 28 ELEGANT: Elacestrant VS Standard Endocrine Therapy in Women and Men With Node-Positive, Estrogen Receptor-Positive, HER2-Negative, Early Breast Cancer With High Risk of Recurrence in a Global, Multicenter, Randomized, Open-Label Phase 3 Study

Publication
Article
Miami Breast Cancer Conference® Abstracts Supplement42nd Annual Miami Breast Cancer Conference® - Abstracts
Volume 39
Issue 4
Pages: 19-20

TPS 28 ELEGANT: Elacestrant VS Standard Endocrine Therapy in Women and Men With Node-Positive, Estrogen Receptor-Positive, HER2-Negative, Early Breast Cancer With High Risk of Recurrence in a Global, Multicenter, Randomized, Open-Label Phase 3 Study

TPS 28 ELEGANT: Elacestrant VS Standard Endocrine Therapy in Women and Men With Node-Positive, Estrogen Receptor-Positive, HER2-Negative, Early Breast Cancer With High Risk of Recurrence in a Global, Multicenter, Randomized, Open-Label Phase 3 Study

Background

Adjuvant endocrine therapy (ET) is the standard of care (SOC) for treating estrogen receptor–positive (ER+)/HER2-negative (HER2–) early breast cancer (EBC). Despite advances to optimize adj treatment in high-risk ER+/HER2- EBC, there continues to be a risk of local and metastatic (incurable) recurrence that persists, and new therapies with desirable safety profiles are warranted. Elacestrant is a next-generation oral SERD that provides a novel mechanism of action that has shown both SERD (degradative) and SERM (partial agonist) activity that differs from currently available adjuvant ET. In the EMERALD trial, elacestrant significantly prolonged progression-free survival (PFS) vs SOC ET in the overall population (HR, 0.70; 95% CI, 0.55-0.88; P = .0018) and in patients with ESR1-mutated tumors (HR, 0.55; 95% CI, 0.39-0.77; P = .0005). In patients with ESR1-mutated tumors who received prior ET plus CDK4/6 inhibitor (CDK4.6i) at 12 months or longer, median PFS with elacestrant was 8.6 months vs 1.9 months with SOC ET. In a preoperative, window of opportunity ER+/HER2– EBC trial (SOLTI-1905-ELIPSE), elacestrant was associated with complete cell cycle arrest (defined as Ki67 < 2.7%) rate of 27% and a statistically significant mean change from baseline, shifting tumor biology toward a more endocrine-sensitive and less proliferative tumor phenotype. Given that elacestrant demonstrated efficacy in metastatic breast cancer regardless of ESR1-mutation status relative to SOC ET and has shown biologic activity in EBC, it is hypothesized that elacestrant can prolong invasive breast cancer-free survival (IBCFS) in patients with high-risk EBC who received prior adjuvant ET with or without CDK4/6i.

Materials and Methods

ELEGANT (NCT06492616) is a global, multicenter, open-label phase 3 study designed to evaluate elacestrant vs SOC ET (aromatase inhibitor or tamoxifen) in patients with EBC and a high risk of recurrence. Patients will be randomized 1:1 to continue SOC ET or to elacestrant for a duration of 5 years. Eligible patients are women or men with ER+/HER2− node-positive EBC who have completed 24 to 60 months of adjuvant ET with or without CDK4/6i, and an ECOG performance status of≤1. Patients who received a prior CDK4/6i or a PARP inhibitor must have already completed or discontinued these treatments. Pre/perimenopausal women and men will be administered a LHRH agonist. Exclusion criteria include inflammatory breast cancer, history of prior invasive breast cancer, and > 6 month continuous interruption of prior SOC adjuvant ET or discontinuation of adjuvant ET > 6 months prior to randomization. The primary end point is IBCFS. Key secondary end points include distant relapse-free survival, overall survival, invasive disease-free survival, safety, patient-reported outcomes-quality of life, and pharmacokinetics.

Status

Planned enrollment is 4220 patients; recruitment is ongoing.

Articles in this issue

2 Preventive Care and Screening Adherence Among Women Surviving Breast Cancer
2 Preventive Care and Screening Adherence Among Women Surviving Breast Cancer
3 Intraoperative Radiotherapy: Alive and Well in the Bronx
3 Intraoperative Radiotherapy: Alive and Well in the Bronx
4 Evaluating AI-Driven Responses in Breast Reconstruction: A Comparative Study of Response Formats
4 Evaluating AI-Driven Responses in Breast Reconstruction: A Comparative Study of Response Formats
5 Correlation Between Visual Impairment and Breast Cancer: A Cross-Sectional Study Based on the National Health Interview Surveys
5 Correlation Between Visual Impairment and Breast Cancer: A Cross-Sectional Study Based on the National Health Interview Surveys
6 Peer Support Programming Among Women At-Risk for Surviving Breast Cancer: Facilitators and Barriers to Community-Based Patient Navigation and the Role of Quality of Life
6 Peer Support Programming Among Women At-Risk for Surviving Breast Cancer: Facilitators and Barriers to Community-Based Patient Navigation and the Role of Quality of Life
7 Metaplastic Breast Cancer: A Retrospective Chart Review of Clinical Features
7 Metaplastic Breast Cancer: A Retrospective Chart Review of Clinical Features
8 A Case Series Exploring Characteristics and Outcomes of Metachronous Primary Breast and Lung Cancer in a Diverse Cohort
8 A Case Series Exploring Characteristics and Outcomes of Metachronous Primary Breast and Lung Cancer in a Diverse Cohort
9 Body Mass Index, Cancer Risk Behaviors, and Readiness for Dietary Change Among Women Surviving With Breast Cancer
9 Body Mass Index, Cancer Risk Behaviors, and Readiness for Dietary Change Among Women Surviving With Breast Cancer
10 AI as a Bridge: Can ChatGPT Help Patients Understand Their Breast Radiology Reports?
10 AI as a Bridge: Can ChatGPT Help Patients Understand Their Breast Radiology Reports?
12 Gut Microbiome Composition and Pathological Complete Response After Chemotherapy in Breast Cancer: Insights From a Pilot Study
12 Gut Microbiome Composition and Pathological Complete Response After Chemotherapy in Breast Cancer: Insights From a Pilot Study
13 Preliminary Analysis of Change During Treatment of Financial Toxicity and Quality of Life in Breast Cancer Patients
13 Preliminary Analysis of Change During Treatment of Financial Toxicity and Quality of Life in Breast Cancer Patients
15 Utilizing Circulating Tumor Cells to Guide HER2-Directed Therapy in IHC/FISH-Negative HER2+ Metastatic Breast Cancer
15 Utilizing Circulating Tumor Cells to Guide HER2-Directed Therapy in IHC/FISH-Negative HER2+ Metastatic Breast Cancer
16 A Miami Hospital’s Infrastructure to Help Decrease Late-Stage Breast Cancer Diagnosis and Improve Health Equity
16 A Miami Hospital’s Infrastructure to Help Decrease Late-Stage Breast Cancer Diagnosis and Improve Health Equity
17 Salmonella and the Breast: A Literature Review of Salmonella-Induced Breast Abscesses
17 Salmonella and the Breast: A Literature Review of Salmonella-Induced Breast Abscesses
18 Tolerability of First-Line Treatment With Ribociclib for Metastatic Breast Cancer Using 2 Large US Data Sources
18 Tolerability of First-Line Treatment With Ribociclib for Metastatic Breast Cancer Using 2 Large US Data Sources
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