Breast Cancer
Conditions
Keywords
Elacestrant, advanced breast cancer, Quality of life, ESR1 Mutation, Orserdu
Brief 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.
Interventions
DRUGElacestrant
According to the Summary of Product Characteristics (SmPC)
Treatment decision of investigator
Sponsors
iOMEDICO AG
Berlin Chemie AG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed and dated informed consent form * Postmenopausal women * Age ≥18 years * Eastern Cooperative Oncology Group Performance Status (ECOG) \< 2 * Locally advanced and/or metastatic ER+ HER2- breast cancer * Histologically proven ER positivity (defined as ≥1% staining by immunohistochemistry (IHC)) * Histologically proven HER2 negativity (defined as a IHC0 or IHC1+ score by IHC or a negative result by in situ hybridization (ISH), optionally combined with a IHC2+ score) * Disease progression following first line ET + CDKi * No more than one prior ET line in the advanced/metastatic setting and intention for 2nd-line treatment with elacestrant according to current elacestrant SmPC as assessed by the treating physician (ESR1 testing can be done after inclusion) * For patients with proven ESR1mut: Study inclusion the latest 2 weeks after start of elacestrant treatment
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in EORTC global health scale | From Time of enrollment until month 11 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to deterioration in global health scale (EORTC QLQ-C30) | From Time of enrollment until month 11 | 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 to deterioration in functional scores (EORTC QLQ-C30) | From Time of enrollment until month 11 | 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 to deterioration in symptom scores (EORTC QLQ-C30) | From Time of enrollment until month 11 | 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. |
| Change from baseline in functional and symptom scores | From Time of enrolment until up to 11 months after enrolment. | 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. |
| Change from baseline in visual analogue scale (VAS) | From Time of enrollment until month 11. | Change from baseline in EQ-5D-5L visual analogue scale (VAS); The EQ-5D-5L VAS ranges from 0 to 100, with higher scores indicating better quality of life. |
| Change from baseline in index value | From Time of enrollment until month 11. | Change from baseline in EQ-5D-5L Index Value The EQ-5D-5L index value ranges from -0.661 to 1, with higher scores indicating better quality of life. |
| Change from baseline in all scales of EQ-5D-5L | From Time of enrollment until month 11. | Change from baseline in all scales of EQ-5D-5L The scales of EQ-5D-5L range from 1 to 5, with lower scores indicating better quality of life. |
| Prevalence of ESR1 mutation | Baseline | Assess prevalence of ESR1mut in patients intended for elacestrant treatment as well as the testing methodology and results for ESR1 mutations. |
| Drug safety: Frequency | From time of treatment start until 30 days after end of elacestrant treatment | Frequency of specific (serious) adverse drug reactions ((S)ADRs) (nausea, vomiting, decreased appetite) |
| Drug safety: Incidence of adverse events | From time of treatment start until 30 days after end of elacestrant treatment | Incidence of (serious) adverse events ((S)AEs), (serious) adverse drug reactions ((S)ADRs) |
| Drug safety: Change from baseline in AST (Aspartate Aminotransferase) | From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months) | Change from baseline in AST |
| Drug safety: Change from baseline in ALT (Alanine Aminotransferase) | From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months) | Change from baseline in ALT |
| Drug safety: Change from baseline in bilirubin | From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months) | Change from baseline in bilirubin |
| Patients and disease characteristics: Age | Baseline | Assess patients characteristics in patients with intention for treatment with elacestrant: Age (descriptive statistics, categorical (\</≥ 65)) |
| Patients and disease characteristics: Body mass index (BMI) | Baseline | Assess patients characteristics in patients with intention for treatment with elacestrant: BMI (descriptive statistics, categorical (underweight, normal weight, overweight, obese)) |
| Patients and disease characteristics: ECOG Performance status | Baseline | Assess patients characteristics in patients with intention for treatment with elacestrant: ECOG Performance status |
| Patients and disease characteristics: CCI (Charlson score and contributing diseases) | Baseline | Assess patients characteristics in patients with intention for treatment with elacestrant: CCI (Charlson score and contributing diseases) |
| Patients and disease characteristics: Time since diagnosis | Baseline | Assess disease characteristics in patients with intention for treatment with elacestrant: Time since diagnosis (descriptive statistics) |
| Patients and disease characteristics: TNM staging | Baseline | Assess disease characteristics in patients with intention for treatment with elacestrant: TNM staging (including AJCC) at initial diagnosis |
| Patients and disease characteristics: Metastatic sites | Baseline | Assess disease characteristics in patients with intention for treatment with elacestrant: • Metastatic sites at inclusion |
| Patients and disease characteristics: Tumor Grading | Baseline | Assess disease characteristics in patients with intention for treatment with elacestrant: Tumor Grading at initial diagnosis and inclusion |
| Patients and disease characteristics: HR and HER2 status | Baseline | Assess disease characteristics in patients with intention for treatment with elacestrant: HR status and HER2 status at initial diagnosis and at inclusion |
| Patients and disease characteristics: Prior adjuvant chemotherapy | Baseline | Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant chemotherapy |
| Patients and disease characteristics: Prior adjuvant endocrine therapy | Baseline | Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant endocrine therapy |
| Patients and disease characteristics: prior CDKi/endocrine therapy in the palliative setting | Baseline | Assess disease characteristics in patients with intention for treatment with elacestrant: Type and duration of prior CDKi/endocrine therapy in the palliative setting (descriptive statistics, categorical ≤6 months / \>6 months; ≤12 months / \>12 months) |
| Patients and disease characteristics: Disease site | At time of enrollment | Assess disease characteristics in patients with intention for treatment with elacestrant: Disease site (bone-only / visceral / non-visceral (not bone-only)) at inclusion |
| Patients and disease characteristics: concomitant diseases | Baseline | Assess disease characteristics in patients with intention for treatment with elacestrant: concomitant diseases |
| Use of concomitant medication | max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment) | Assess the use of concomitant medication during treatment with elacestrant. |
| Assess parameters of physicians' treatment decision making using a questionnaire | Baseline | Frequency of distinct parameters affecting therapy choice; questionnaire completed by treating physician. |
| Frequency of first subsequent systemic antineoplastic therapy for ESR1wt patients and ESR1mut patients without elacestrant treatment | max. 24 months; at patient patient-specific start of treatment | Assess second-line treatments for all patients by ESR1 status (Frequency of first subsequent systemic antineoplastic therapy for ESR1wt patients and ESR1mut patients without elacestrant treatment (refers to first treatment received starting from second line) |
| Details on treatment with elacestrant: reason for end of treatment | max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment) | Assess reason for end of treatment (treatment with elacestrant) |
| Details on treatment with elacestrant: dose intensity | max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment) | Assess dose intensity (treatment with elacestrant) as prescribed by the treating physician |
| Details on treatment with elacestrant: frequency and type of dose modification | max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment) | Assess Frequency and type of dose modifications (dose reductions, interruptions) compared to SmPC of elacestrant. |
| Details on treatment with elacestrant: reasons for dose modifications and interruptions | max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment) | Assess reasons for dose modifications and interruptions (elacestrant treatment) |
| Treatments following elacestrant therapy: Type of first subsequent systemic antineoplastic therapy | max. 24 months; from the patient-specific end of elacestrant treatment until end of study | Details on treatments following elacestrant therapy (Type of first subsequent systemic antineoplastic therapy) |
| Treatments following elacestrant therapy: Frequency of first subsequent systemic antineoplastic therapy | max. 24 months; from the patient-specific end of elacestrant treatment until end of study | Details on treatments following elacestrant therapy:Frequency of first subsequent systemic antineoplastic therapy for ESR1mut patients (refers to first treatment received after Elacestrant so starting from third line) |
Countries
Germany
Contacts
CONTACTLaura Serrer
PRINCIPAL_INVESTIGATORThomas Decker, Professor
Gemeinschaftspraxis für Hämatologie und Onkologie GbR Ravensburg
PRINCIPAL_INVESTIGATORMichael Patrick Lux, Professor
St. Louise Frauen- und Kinderklinik Paderborn
Outcome results
None listed