A Treatment With Fulvestrant and Exemestane in Postmenopausal Patients With Advanced Hormone Receptor-Positive (HR) + Breast Cancer
NCT ID: NCT01171417
Last Updated: 2014-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
570 participants
OBSERVATIONAL
2010-08-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1
1st-line Faslodex 500 mg
No interventions assigned to this group
Cohort 2
2nd-line Faslodex 500 mg
No interventions assigned to this group
Cohort 3
3rd- line Faslodex 500 mg
No interventions assigned to this group
Cohort 4
patients on exemestane
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Nicolai Maass, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
52074 Aachen, Germany
Locations
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Research Site
Aachen, , Germany
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Ahaus, , Germany
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Amberg, , Germany
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Aschaffenburg, , Germany
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Aschersleben, , Germany
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Bad Nauheim, , Germany
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Bad Segeberg, , Germany
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Bamberg, , Germany
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Bergisch Gladbach, , Germany
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Berlin, , Germany
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Bielefeld, , Germany
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Bonn, , Germany
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Böblingen, , Germany
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Braunschweig, , Germany
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Castrop-Rauxel, , Germany
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Chemnitz, , Germany
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Cologne, , Germany
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Dachau, , Germany
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Donauwurth, , Germany
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Dortmund, , Germany
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Dresden, , Germany
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Düsseldorf, , Germany
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Eggenfelden, , Germany
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Erfurt, , Germany
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Eschweiler, , Germany
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Essen, , Germany
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Esslingen am Neckar, , Germany
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Euskirchen, , Germany
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Frankfurt, , Germany
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Frechen, , Germany
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Freiburg im Breisgau, , Germany
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Fürstenwalde, , Germany
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Geesthacht, , Germany
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Gera, , Germany
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Goslar, , Germany
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Göttingen, , Germany
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Gröbenzell, , Germany
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Hamburg, , Germany
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Hanau, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Heidenheim, , Germany
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Herdecke, , Germany
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Hof, , Germany
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Ilsede, , Germany
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Ingolstadt, , Germany
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Karlsruhe, , Germany
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Kassel, , Germany
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Kiel, , Germany
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Landshut, , Germany
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Langen, , Germany
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Lehrte, , Germany
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Ludwigsburg, , Germany
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Lübeck, , Germany
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Magdeburg, , Germany
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Mayen, , Germany
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Memmingen, , Germany
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Mittweida, , Germany
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Moers, , Germany
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Mönchengladbach, , Germany
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Mühlhausen, , Germany
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München, , Germany
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Münster, , Germany
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Naunhof, , Germany
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Nordhausen, , Germany
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Nordhorn, , Germany
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Nuremberg, , Germany
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Oberhausen, , Germany
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Offenbach, , Germany
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Osnabrück, , Germany
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Passau, , Germany
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Plüderhausen, , Germany
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Remagen, , Germany
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Remscheid, , Germany
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Rendsburg, , Germany
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Rodewisch, , Germany
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Rodgau, , Germany
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Simmern, , Germany
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Soest, , Germany
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Stendal, , Germany
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Stralsund, , Germany
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Stuttgart, , Germany
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Troisdorf, , Germany
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Tübingen, , Germany
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Villingen-Schwenningen, , Germany
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Weiden, , Germany
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Wetzlar, , Germany
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Wiesbaden, , Germany
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Worms, , Germany
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Würselen, , Germany
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Würzburg, , Germany
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Zittau, , Germany
Countries
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Other Identifiers
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NIS-ODE-FAS-2009/1
Identifier Type: -
Identifier Source: secondary_id
NIS-ODE-FAS-2009/1
Identifier Type: -
Identifier Source: org_study_id
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