Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsoriOMEDICO AG
About this trial
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.
Eligibility criteria
Qualifiers
Signed and dated informed consent form
Postmenopausal women
Age ≥18 years
Eastern Cooperative Oncology Group Performance Status (ECOG) < 2
Disqualifiers
Prior chemotherapy in the advanced/metastatic setting
Contraindications according to elacestrant SmPC, except for ESR1 test result for patients included prior to ESR1 testing.
Participation in an interventional clinical trial within 30 days prior to enrolment or simultaneous participation in an interventional clinical trial (except follow-up phase)
Trial design
Treatments tested in this trial
- Elacestrant
- Standard of care (Investigator Choice)
Treatment groups
500 Participants
are divided into 2 treatment groupsSponsors and collaborators
iOMEDICO AG
Lead sponsor
Berlin Chemie AG
Collaborator
Source ClinicalTrials.gov