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Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer
Sponsor: iOMEDICO AG
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
Elacestrant
According to the Summary of Product Characteristics (SmPC)
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