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| Name | Class |
|---|---|
| Berlin Chemie AG | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESR1 wildtype | Patients with a ESR1 wildtype tumor |
| |
| ESR1 mutated | Patients with a ESR1 mutated tumor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elacestrant | Drug | According to the Summary of Product Characteristics (SmPC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Time of enrollment until month 11 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Time of enrollment until month 11 |
| Time to deterioration in functional scores (EORTC QLQ-C30) |
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Inclusion Criteria:
Exclusion Criteria
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Serrer | Contact | +49761152420 | eleni@iomedico.com |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Decker, Professor | Gemeinschaftspraxis für Hämatologie und Onkologie GbR Ravensburg | Principal Investigator |
| Michael Patrick Lux, Professor | St. Louise Frauen- und Kinderklinik Paderborn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Praxis für interdisziplinäre Onkologie & Hämatologie | Recruiting | Freiburg im Breisgau | 79110 | Germany |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000626176 | elacestrant |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care (Investigator Choice) | Drug | Treatment decision of investigator |
|
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. |
| From Time of enrollment until month 11 |
| 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. | From Time of enrollment until month 11 |
| 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. | From Time of enrolment until up to 11 months after enrolment. |
| Change from baseline in visual analogue scale (VAS) | 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. | From Time of enrollment until month 11. |
| Change from baseline in index value | 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. | From Time of enrollment until month 11. |
| Change from baseline in all scales of EQ-5D-5L | 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. | From Time of enrollment until month 11. |
| Prevalence of ESR1 mutation | Assess prevalence of ESR1mut in patients intended for elacestrant treatment as well as the testing methodology and results for ESR1 mutations. | Baseline |
| Drug safety: Frequency | Frequency of specific (serious) adverse drug reactions ((S)ADRs) (nausea, vomiting, decreased appetite) | From time of treatment start until 30 days after end of elacestrant treatment |
| Drug safety: Incidence of adverse events | Incidence of (serious) adverse events ((S)AEs), (serious) adverse drug reactions ((S)ADRs) | From time of treatment start until 30 days after end of elacestrant treatment |
| Drug safety: Change from baseline in AST (Aspartate Aminotransferase) | Change from baseline in AST | From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months) |
| Drug safety: Change from baseline in ALT (Alanine Aminotransferase) | Change from baseline in ALT | From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months) |
| Drug safety: Change from baseline in bilirubin | Change from baseline in bilirubin | From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months) |
| Patients and disease characteristics: Age | Assess patients characteristics in patients with intention for treatment with elacestrant: Age (descriptive statistics, categorical (\ | Baseline |
| Patients and disease characteristics: Body mass index (BMI) | Assess patients characteristics in patients with intention for treatment with elacestrant: BMI (descriptive statistics, categorical (underweight, normal weight, overweight, obese)) | Baseline |
| Patients and disease characteristics: ECOG Performance status | Assess patients characteristics in patients with intention for treatment with elacestrant: ECOG Performance status | Baseline |
| Patients and disease characteristics: CCI (Charlson score and contributing diseases) | Assess patients characteristics in patients with intention for treatment with elacestrant: CCI (Charlson score and contributing diseases) | Baseline |
| Patients and disease characteristics: Time since diagnosis | Assess disease characteristics in patients with intention for treatment with elacestrant: Time since diagnosis (descriptive statistics) | Baseline |
| Patients and disease characteristics: TNM staging | Assess disease characteristics in patients with intention for treatment with elacestrant: TNM staging (including AJCC) at initial diagnosis | Baseline |
| Patients and disease characteristics: Metastatic sites | Assess disease characteristics in patients with intention for treatment with elacestrant: • Metastatic sites at inclusion | Baseline |
| Patients and disease characteristics: Tumor Grading | Assess disease characteristics in patients with intention for treatment with elacestrant: Tumor Grading at initial diagnosis and inclusion | Baseline |
| Patients and disease characteristics: HR and HER2 status | Assess disease characteristics in patients with intention for treatment with elacestrant: HR status and HER2 status at initial diagnosis and at inclusion | Baseline |
| Patients and disease characteristics: Prior adjuvant chemotherapy | Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant chemotherapy | Baseline |
| Patients and disease characteristics: Prior adjuvant endocrine therapy | Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant endocrine therapy | Baseline |
| Patients and disease characteristics: prior CDKi/endocrine therapy in the palliative setting | 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) | Baseline |
| Patients and disease characteristics: Disease site | Assess disease characteristics in patients with intention for treatment with elacestrant: Disease site (bone-only / visceral / non-visceral (not bone-only)) at inclusion | At time of enrollment |
| Patients and disease characteristics: concomitant diseases | Assess disease characteristics in patients with intention for treatment with elacestrant: concomitant diseases | Baseline |
| Use of concomitant medication | Assess the use of concomitant medication during treatment with elacestrant. | max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment) |
| Assess parameters of physicians' treatment decision making using a questionnaire | Frequency of distinct parameters affecting therapy choice; questionnaire completed by treating physician. | Baseline |
| Frequency of first subsequent systemic antineoplastic therapy for ESR1wt patients and ESR1mut patients without elacestrant 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) | max. 24 months; at patient patient-specific start of treatment |
| Details on treatment with elacestrant: reason for end of treatment | Assess reason for end of treatment (treatment with elacestrant) | max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment) |
| Details on treatment with elacestrant: dose intensity | Assess dose intensity (treatment with elacestrant) as prescribed by the treating physician | max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment) |
| Details on treatment with elacestrant: frequency and type of dose modification | Assess Frequency and type of dose modifications (dose reductions, interruptions) compared to SmPC of elacestrant. | max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment) |
| Details on treatment with elacestrant: reasons for dose modifications and interruptions | Assess reasons for dose modifications and interruptions (elacestrant treatment) | max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment) |
| Treatments following elacestrant therapy: Type of first subsequent systemic antineoplastic therapy | Details on 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 |
| Treatments following elacestrant therapy: Frequency of first subsequent systemic antineoplastic therapy | 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) | max. 24 months; from the patient-specific end of elacestrant treatment until end of study |
| St. Louise Frauen- und Kinderklinik | Recruiting | Paderborn | 33098 | Germany |
|
| Gemeinschaftspraxis für Hämatologie und Onkologie | Recruiting | Ravensburg | 88212 | Germany |
|
| D017437 |
| Skin and Connective Tissue Diseases |