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
This trial does not accept healthy volunteersQualifiers
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 population
Postmenopausal women with locally advanced and/or metastatic estrogen receptor-positive (ER+) human epidermal growth factor receptor 2-negative (HER2)- breast cancer with disease progression on endocrine therapy and cyclin-dependent kinase inhibitor (CDKi) and intention for second line (2L) treatment with elacestrant according to summary of product characteristics (SmPC).
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Elacestrant
DrugAccording to the Summary of Product Characteristics (SmPC)
Standard of care (Investigator Choice)
DrugTreatment decision of investigator
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: ESR1 wildtype1 intervention
Group B: ESR1 mutated1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in EORTC global health scale
Change from baseline quality of life (QoL) over time for the global health scale of the EORTC QLQ- C30 questionnaire The EORTC QLQ- C30 global health scale ranges from 0 to 100, with higher scores indicating better quality of life.
Time frame
From Time of enrollment until month 11Secondary outcomes
1
Time to deterioration in global health scale (EORTC QLQ-C30)
Time to deterioration in global health scale of EORTC QLQ-C30 The EORTC QLQ- C30 global health scale ranges from 0 to 100, with higher scores indicating better quality of life.
Time frame
From Time of enrollment until month 112
Time to deterioration in functional scores (EORTC QLQ-C30)
Time to deterioration in functional scores of EORTC QLQ-C30. The EORTC QLQ- C30 functional score ranges from 0 to 100, with higher scores indicating better quality of life.
Time frame
From Time of enrollment until month 113
Time to deterioration in symptom scores (EORTC QLQ-C30)
Time to deterioration in symptom scores of EORTC QLQ-C30 The EORTC QLQ- C30 symptom score ranges from 0 to 100, with lower scores indicating better quality of life.
Time frame
From Time of enrollment until month 114
Change from baseline in functional and symptom scores
Change from baseline in functional and symptom scores of EORTC QLQ-C30 The EORTC QLQ- C30 functional and symptom scores ranges from 0 to 100, with higher scores indicating better quality of life (for functional scores), and lower indication better quality of life for symptom scores.
Time frame
From Time of enrolment until up to 11 months after enrolment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
iOMEDICO AG
Lead sponsor
Berlin Chemie AG
Collaborator
Source ClinicalTrials.gov