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Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer

NCT07563595 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-05-04

No results posted yet for this study

Summary

The objective of this non-interventional study (NIS) is to evaluate prevalence of ESR1 mutation after endocrine therapy in the palliative setting, quality of life, tolerability, and safety and to describe treatment detail and adverse event (AE) management in postmenopausal women with locally advanced and/or metastatic ER+ HER2- ESR1-mutated breast cancer and second line treatment with elacestrant according to SmPC (Summary of product characteristics) in a real-world setting.

Conditions

Interventions

DRUG

Elacestrant

According to the Summary of Product Characteristics (SmPC)

DRUG

Standard of care (Investigator Choice)

Treatment decision of investigator

Sponsors & Collaborators

  • Berlin Chemie AG

    collaborator UNKNOWN

  • iOMEDICO AG

    lead INDUSTRY

Principal Investigators

  • Thomas Decker, Professor · Gemeinschaftspraxis für Hämatologie und Onkologie GbR Ravensburg

  • Michael Patrick Lux, Professor · St. Louise Frauen- und Kinderklinik Paderborn

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-05-31
Completion
2029-07-31

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 NCT07563595 on ClinicalTrials.gov