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RECRUITING
NCT07563595

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

Sponsor: iOMEDICO AG

View on ClinicalTrials.gov

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.

Official title: Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer: a Multicenter, National, Prospective Non-interventional Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2026-06-19

Completion Date

2028-06

Last Updated

2026-06-25

Healthy Volunteers

No

Conditions

Interventions

DRUG

Elacestrant

According to the Summary of Product Characteristics (SmPC)

DRUG

Standard of care (Investigator Choice)

Treatment decision of investigator

Locations (3)

Praxis für interdisziplinäre Onkologie & Hämatologie

Freiburg im Breisgau, Germany

St. Louise Frauen- und Kinderklinik

Paderborn, Germany

Gemeinschaftspraxis für Hämatologie und Onkologie

Ravensburg, Germany