CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 220 target
Drug / intervention
Elacestrant +4 moredrug
Likely dose
Letrozole 2.5mgfrom record
Key inclusion· 13
  • ✓Female or male patients with histologically confirmed ER+ HER2- breast cancer
  • ✓Intermediate to high risk of recurrence after definitive treatment
  • ✓≥4 positive axillary lymph nodes (stage pN2-3)
  • ✓1-3 positive lymph nodes with tumor size ≥5cm or grade 3 or Ki67≥20% or high genomic risk
Key exclusion· 16
  • ✕Suspected recurrent disease
  • ✕Prior treatment with any SERD or investigational ER antagonist
  • ✕Previous history of invasive breast cancer
  • ✕Other malignancy within last 5 years (except skin cancer or carcinoma in situ)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05512364
NCT05512364Phase 3RecruitingOn Track
CompareCT.gov

Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse

European Organisation for Research and Treatment of Cancer - EORTC·interventional·Posted Aug 23, 2022·Updated May 15, 2026

In Brief

A Phase 3 clinical trial evaluating Elacestrant, Tamoxifen, and 3 other interventions for ER-positive Breast Cancer and 3 related conditions. Currently recruiting, targeting 220 participants across 109 sites in 12 countries.

Detailed Summary

This is an international, multi-center, randomised, open label, superiority phase III trial of elacestrant vs standard endocrine therapy in patients with ER+/HER2- breast cancer and ctDNA relapse. During the ctDNA screening phase, patients will be tested at different timepoints to detect the presence of ctDNA in their blood. Patients who are found to be ctDNA-positive and have no evidence of distant metastasis, will be randomised 1:1 between standard endocrine treatment (the same they were receiving when tested ctDNA positive) versus elacestrant, provided they meet all eligibility criteria. After completion of the protocol treatment period, treatment will be left at the discretion of the treating physician.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsER-positive Breast Cancer, HER2-negative Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer
CountriesBelgium, Cyprus, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, Switzerland
CollaboratorsMenarini Group, Natera, Inc., Borstkanker Onderzoek Groep, Cancer Trials Ireland, SOLTI Breast Cancer Research Group, ETOP IBCSG Partners Foundation, SUCCESS, Hellenic Cooperative Oncology Group, Hellenic Oncology Research Group, Swedish Breast Cancer Group

Timeline

Phase 3Recruiting
20232024202520262027202820292030203120322033203420352036
First PostedAug 23, 2022
Enrollment StartDec 15, 2023
Primary CompletionNov 1, 2032
Study CompletionNov 1, 2035
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 3.9 years agoPrimary completion in 6.3 years

Interventions

Elacestrantdrug

400mg QD orally on a continuous dosing schedule

Tamoxifendrug

20 mg QD orally on a continuous dosing schedule

Letrozole 2.5mgdrug

2.5 mg QD orally on a continuous dosing schedule

Anastrozole 1mgdrug

1 mg QD orally on a continuous dosing schedule

Exemestane 25 MGdrug

25 mg QD orally on a continuous dosing schedule