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Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinically High-risk ER+/HER2- eBC

NCT07242352 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1520

Last updated 2026-05-06

No results posted yet for this study

Summary

In this clinical trial, the Sponsor plans to investigate whether patients with HR+/HER2- eBC identified during routine clinical assessments and treatments as having intermediate to high-risk (based on Oncotype DX® or similar tests and on response assessment to 2-6 weeks of preoperative ET) achieve a survival benefit from an initial 5-years use of elacestrant (with or without a CDK 4/6 inhibitor) followed by SoC ET for further 0-2.5 years in comparison to at least 5 up to 7.5 years SoC ET therapy (+/- CDK4/6 inhibitor).

Based on several studies in the metastatic setting, it is reasonable to assume that the adjuvant use of elacestrant with or without CDK 4/6 inhibitors will prevent or delay the activation of mechanisms conferring resistance to ET (e.g., ESR1 mutations).

Conditions

Interventions

DRUG

Elacestrant

Elacestrant, a tetrahydronaphthalene compound, is a potent, selective, and orally active oestrogen receptor-α (ERα) antagonist and degrader.

DRUG

Standard-of-care endocrine treatment

SoC ET comprises all endocrine treatments authorized for the condition under review. The choice is made upon investigator´s discretion.

Sponsors & Collaborators

  • Berlin-Chemie Menarini

    collaborator INDUSTRY

  • West German Study Group

    lead OTHER

Principal Investigators

  • Peter Schmid, PHD Dr · Fliethstraße 112-114 41061 Moenchengladbach Germany

  • NAdia Harbeck, Prof Dr · Breast Centre, Dept. Obstetrics & Gynaecology and CCC Munich LMU University Hospital Munich Germany

  • Oleg Gluz, Prof Dr · Breast Centre, Evang. Bethesda-Hospital Moenchengladbach Germany

  • Sherko Kuemmel, Prof Dr · Breast Centre, Kliniken Essen Mitte Essen Germany

  • Monika Graeser, PD Dr · Breast Centre, Marien-Hospital Witten Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-29
Primary Completion
2033-09-30
Completion
2033-09-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07242352 on ClinicalTrials.gov