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| ID | Type | Description | Link |
|---|---|---|---|
| NIS-ODE-FAS-2009/1 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | 1st-line Faslodex 500 mg | ||
| Cohort 2 | 2nd-line Faslodex 500 mg | ||
| Cohort 3 | 3rd- line Faslodex 500 mg | ||
| Cohort 4 | patients on exemestane |
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| 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 ) |
| 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. |
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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
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*
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
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660 patients in 140 sites in Germany. 100 specialists and 40 hospitals. Each site should enrol 4-20 patients
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| Name | Affiliation | Role |
|---|---|---|
| Nicolai Maass, Prof. Dr. med. | 52074 Aachen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aachen | Germany | ||||
| Research Site |
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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 |
| Ahaus |
| Germany |
| Research Site | Amberg | Germany |
| Research Site | Aschaffenburg | Germany |
| Research Site | Aschersleben | Germany |
| Research Site | Bad Nauheim | Germany |
| Research Site | Bad Segeberg | Germany |
| Research Site | Bamberg | Germany |
| Research Site | Bergisch Gladbach | Germany |
| Research Site | Berlin | Germany |
| Research Site | Bielefeld | Germany |
| Research Site | Bonn | Germany |
| Research Site | Böblingen | Germany |
| Research Site | Braunschweig | Germany |
| Research Site | Castrop-Rauxel | Germany |
| Research Site | Chemnitz | Germany |
| Research Site | Cologne | Germany |
| Research Site | Dachau | Germany |
| Research Site | Donauwurth | Germany |
| Research Site | Dortmund | Germany |
| Research Site | Dresden | Germany |
| Research Site | Düsseldorf | Germany |
| Research Site | Eggenfelden | Germany |
| Research Site | Erfurt | Germany |
| Research Site | Eschweiler | Germany |
| Research Site | Essen | Germany |
| Research Site | Esslingen am Neckar | Germany |
| Research Site | Euskirchen | Germany |
| Research Site | Frankfurt | Germany |
| Research Site | Frechen | Germany |
| Research Site | Freiburg im Breisgau | Germany |
| Research Site | Fürstenwalde | Germany |
| Research Site | Geesthacht | Germany |
| Research Site | Gera | Germany |
| Research Site | Goslar | Germany |
| Research Site | Göttingen | Germany |
| Research Site | Gröbenzell | Germany |
| Research Site | Hamburg | Germany |
| Research Site | Hanau | Germany |
| Research Site | Hanover | Germany |
| Research Site | Heidelberg | Germany |
| Research Site | Heidenheim | Germany |
| Research Site | Herdecke | Germany |
| Research Site | Hof | Germany |
| Research Site | Ilsede | Germany |
| Research Site | Ingolstadt | Germany |
| Research Site | Karlsruhe | Germany |
| Research Site | Kassel | Germany |
| Research Site | Kiel | Germany |
| Research Site | Landshut | Germany |
| Research Site | Langen | Germany |
| Research Site | Lehrte | Germany |
| Research Site | Ludwigsburg | Germany |
| Research Site | Lübeck | Germany |
| Research Site | Magdeburg | Germany |
| Research Site | Mayen | Germany |
| Research Site | Memmingen | Germany |
| Research Site | Mittweida | Germany |
| Research Site | Moers | Germany |
| Research Site | Mönchengladbach | Germany |
| Research Site | Mühlhausen | Germany |
| Research Site | München | Germany |
| Research Site | Münster | Germany |
| Research Site | Naunhof | Germany |
| Research Site | Nordhausen | Germany |
| Research Site | Nordhorn | Germany |
| Research Site | Nuremberg | Germany |
| Research Site | Oberhausen | Germany |
| Research Site | Offenbach | Germany |
| Research Site | Osnabrück | Germany |
| Research Site | Passau | Germany |
| Research Site | Plüderhausen | Germany |
| Research Site | Remagen | Germany |
| Research Site | Remscheid | Germany |
| Research Site | Rendsburg | Germany |
| Research Site | Rodewisch | Germany |
| Research Site | Rodgau | Germany |
| Research Site | Simmern | Germany |
| Research Site | Soest | Germany |
| Research Site | Stendal | Germany |
| Research Site | Stralsund | Germany |
| Research Site | Stuttgart | Germany |
| Research Site | Troisdorf | Germany |
| Research Site | Tübingen | Germany |
| Research Site | Villingen-Schwenningen | Germany |
| Research Site | Weiden | Germany |
| Research Site | Wetzlar | Germany |
| Research Site | Wiesbaden | Germany |
| Research Site | Worms | Germany |
| Research Site | Würselen | Germany |
| Research Site | Würzburg | Germany |
| Research Site | Zittau | Germany |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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