A Treatment With Fulvestrant and Exemestane in Postmenopausal Patients With Advanced Hormone Receptor-Positive (HR) + Breast Cancer

Study Overview
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Brief Summary
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For patients receiving Faslodex 500 mg, to compare the effectiveness in terms of Time to Progression (TTP) as a function of the line of treatment (i.e. 1st vs. 2nd vs. 3rd line). For all patients, to collect and explore real-life data on the epidemiology and management of Pseudomyxoma Peritonea (PMP) patients with HR+ advanced breast cancer (ABC) treated with Faslodex 500 mg or exemestane.

Official Title
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An Epidemiological Prospective Cohort Study to Describe Treatment Patterns of Fulvestrant And ExemeSTane in Postmenopausal Patients With Advanced HR+ Breast Cancer Under Real-life Conditions in GERmany

Conditions
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Postmenopause, Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent Female postmenopausal patient (or patient post-ovariectomy) and age ≥18 years Postmenopause ist defined as Age ≥ 60 years and natural menopause with menses > 1year ago or FSH and E2 levels in the postmenopausal range or Patients who had bilateral ovariectomy (NCCN V.I. 2009) Histologically confirmed ER+ locally advanced or metastatic breast cancer Not eligible for curative therapy Prior treatment with tamoxifen Suitable to undergo endocrine treatment for ER+ ABC with SERD / sAI Patient is able to read and understand German Exclusion Criteria: Known hypersensitivity to Faslodex or Exemestane or any compounds of the drugs Prior treatment with Faslodex 500 mg or Faslodex 250 mg* for patients who receive treatment with Faslodex 500 mg within this observational study. Patients who are included in the exemestane arm may have received prior Faslodex treatment. Prior treatment with Exemestane for patients who receive treatment with Exemestane within this observational study Acutely life threatening disease Treatment with Faslodex 250 mg/month (previously approved dose) Prior palliative chemotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>1st-line Faslodex 500 mg | |
| Cohort 2<br>2nd-line Faslodex 500 mg | |
| Cohort 3<br>3rd- line Faslodex 500 mg | |
| Cohort 4<br>patients on exemestane | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effectiveness of Faslodex 500 mg in terms of time to progression (TTP) of disease. |  | Period from inclusion up to 9 months (average time period ) | 
| Disease management data | The analysis will be adjusted for the main prognostic factors, such as visceral metastases, age, receptor status etc | Period from inclusion up to 9 months (average time period ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-life data on patient outcomes by line of treatment (i.e. 1st vs. 2nd vs. 3rd line). | Including overall survival (OS), progression-free survival (PFS),time to progression (TTP), response rate (RR) and clinical benefit rate (CBR) | Every 3 months | 
| Real-life pharmacoeconomic data and use of health care resources. | According to lines of treatment and other patient related factors (such as age, co-morbidities etc.), including primary care visits, hospital stays and other resource | Every 3 months | 
| Health-related quality of life (HRQoL) in patients undergoing treatment with Faslodex 500 mg or exemestane. | Health-related quality of life will be assessed with a patient-based instrument (eg, EQ5D). | Every 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fulvestrant, Exemestane, postmenopausal patients, advanced HR+ breast cancer, Hormone Receptor positive, advanced breast cancer