Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Despite treatment improvements in breast cancer, a large number of patients still progress to the metastatic stage. Metastatic breast cancer patients have an extremely unfavorable prognosis. Not only efficacy, but also quality of life are in the focus when planning a therapy or therapy sequence for metastatic breast cancer patients. Therapy options include anti-hormonal Therapy, antibody therapies, other targeted therapies and chemotherapies. One of the most effective chemotherapies in the adjuadjuvant and metastatic setting is paclitaxel. However drug handling and its side effects can compromise patients quality of life and can have an impact on the pharmacokinetics of the drug.
In metastatic breast cancer patients increasing therapy efficacy and reduction of side effect frequency are considered to be advancements of therapy. One of these advancements is the development of a cremophor free and albumin bound paclitaxel, nab-Paclitaxel (Abraxane), which is thought to have a better efficacy and reduced toxicity profile. Nab-Paclitaxel is approved for the treatment of metastatic breast cancer after a failure of first-line therapy and when antracyclines are not indicated.
The SERAPHINA study aims to investigate in the use of nab-Paclitaxel in daily routine and the frequency and perception of side effects.
As a non-interventional study, the SERAPHINA Study will assess the patient characteristics and describe the patient cohort, in which nab-Paclitaxel is given. This includes age distribution and characteristics documented by the patients themselves.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Epidemiological assessment of progression free survival (PFS) under real life conditions. | PFS defined as the time to the first progression or death after therapy start of nab-Paclitaxel. | A patient remains in the study for a maximum of 36 months or until death, whatever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of other prognostic characteristics | OS (overall survival) is defined as the time to death from therapy start of nab-Paclitaxel. Reason for death is taken into consideration as well (BBCS, breast cancer specific survival). | A patient remains in the study for a maximum of 36 months or until death, whatever occurs first |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
1200 patients with locally advanced/metastatic breast cancer for who is curruently or will be treated with nab-Paclitaxel according to the approval as stated in the Summary of Product Characteristics.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Fasching, Prof. Dr. | Frauenklinik des Universitätsfrauenklinikums Erlangen | Principal Investigator |
| Hans Joachim Lück, Prof. Dr. | Gynäkologisch-Onkologische Schwerpunktpraxis am Pelikanplatz | Principal Investigator |
| Diethelm Wallwiener, Prof. Dr. | Universitätsklinikum Tübingen Universitäts-Frauenklinik | Study Director |
| Sara Brucker, Prof. Dr. | Universitätsklinikum Tübingen Universitäts-Frauenklinik | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalen Brustzentrum | Aalen | Baden-Wurttemberg | 73430 | Germany | ||
| Universitätsklinikum Freiburg |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Blood samples
| Influence of age on the prognosis and quality of life. |
Progression free survival, overall survival and quality of life assessed with PRO |
| A patient remains in the study for a maximum of 36 months or until death, whatever occurs first |
| Incidence of adverse events, serious adverse events will be reported. | NCI Common Toxicity Criteria Version 4.03 | A patient remains in the study for a maximum of 36 months or until death, whatever occurs first |
| Quality of life (FACT-B -Taxane, Version 4, nab-Paclitaxel specific questions, NCCN-Distress-Thermometer) | Patient reported (PRO) quality of life is assessed with standardized questionnaires (FACT-B, Version 4, FACT-Taxane, Version 4, nab-Paclitaxel specific questions, NCCN-Distress-Thermometer. | A patient remains in the study for a maximum of 36 months or until death, whatever occurs first |
| Influence of breast cancerpatient characteristics on prognosis, adverse event frequencies, quality of life and therapy decision making. | The patient group is described by patient and tumor characteristics and a series of questionnaires assessing health and socioeconomic status and geriatric assessment status. These parameters that describe the patient cohort will be analyzed with regard to their influence on prognosis, adverse event frequencies, quality of life and therapy decision making. | A patient remains in the study for a maximum of 36 months or until death, whatever occurs first |
| Freiburg im Breisgau |
| Baden-Wurttemberg |
| 79106 |
| Germany |
| NCT Heidelberg | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Frauenklinik des Städtischen Klinikums | Karlsruhe | Baden-Wurttemberg | 76133 | Germany |
| St. Vicentius Kliniken gAG | Karlsruhe | Baden-Wurttemberg | 76135 | Germany |
| Ortenau Klinikum Lahr-Ettenheim | Lahr | Baden-Wurttemberg | 77933 | Germany |
| Praxisklinik am Rosengarten | Mannheim | Baden-Wurttemberg | 68165 | Germany |
| Universitätsmedizin Mannheim | Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Paracelsus Krankenhaus Ruit | Ruit | Baden-Wurttemberg | 73760 | Germany |
| Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie | Singen | Baden-Wurttemberg | 78224 | Germany |
| Brustzentrum | Stuttgart | Baden-Wurttemberg | 70176 | Germany |
| Universitätsfrauenklinik Tübingen | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| GRN-Klinik Weinheim Abteilung für Gynäkologie und Geburtshilfe | Weinheim | Baden-Wurttemberg | 69469 | Germany |
| Klinikum für Frauenheilkunde und Geburtshilfe Esslingen | Esslingen am Neckar | Baden-Württenberg | 73730 | Germany |
| MVZ Amberg | Amberg | Bavaria | 92224 | Germany |
| phase drei Hämato-Onkologischer Studienkreis am Klinikum Aschaffenburg | Aschaffenburg | Bavaria | 63739 | Germany |
| Klinikum Augsburg Frauenklinik | Augsburg | Bavaria | 86156 | Germany |
| Sozialstiftung Bamberg, Klinikum am Bruderwald Klinik für Frauenheilkunde und Geburtshilfe | Bamberg | Bavaria | 96049 | Germany |
| Sozialstiftung Bamberg, Klinikum am Bruderwald Klinik für Frauenheilkunde und Geburtshilfe | Bayreuth | Bavaria | 95445 | Germany |
| Rottal-Inn-Kliniken GmbH | Eggenfelden | Bavaria | 84307 | Germany |
| Universitätsfrauenklinik Erlangen | Erlangen | Bavaria | 91012 | Germany |
| Praxis für Hämatologie Onkologie Palliativmedizin | Landshut | Bavaria | 84028 | Germany |
| Praxisgemeinschaft Dr. med. Steffi Busch | Mühlhausen | Bavaria | 99974 | Germany |
| MOPS Elisenhof MOP-Studiengesellschaft | München | Bavaria | 80335 | Germany |
| Klinikum der Universität München (LMU) | München | Bavaria | 80337 | Germany |
| Praxisgemeinschaft - Frauenärzte am Stadtpark | Nuremberg | Bavaria | 90409 | Germany |
| Caritas-Krankenhaus St. Josef | Regensburg | Bavaria | 93053 | Germany |
| MVZ Weiden GmbH | Weiden | Bavaria | 92637 | Germany |
| Praxis Dr. med. Uwe G. Pöhls und Kollegen Fachärzte für Frauenheilkunde und Geburtshilfe | Würzburg | Bavaria | 97070 | Germany |
| Onkologische Gemeinschaftspraxis | Würzburg | Bavaria | 97080 | Germany |
| Akad. Lehrkrankenhaus der Charité | Ludwigsfelde | Brandenburg | 14947 | Germany |
| Ruppiner Kliniken GmbH | Neuruppin | Brandenburg | 16816 | Germany |
| g.SUND Gynäkologie Kompetenzzentrum | Stralsund | Brandenburg | 18435 | Germany |
| Brustzentrum am Elisabeth-KH Leipzig | Leipzig | Dresden | 04277 | Germany |
| Klinikum Darmstadt | Darmstadt | Hesse | 64283 | Germany |
| Zentrum für Hämatologie und Onkologie Bethanien | Frankfurt am Main | Hesse | 60389 | Germany |
| Agaplesion Markus Krankenhaus | Frankfurt am Main | Hesse | 60431 | Germany |
| MVZ Onkologische Kooperation Harz | Goslar | Hesse | 38643 | Germany |
| Praxis Ammon/Meyer | Göttingen | Hesse | 37073 | Germany |
| Klinikum Kassel GmbH | Kassel | Hesse | 34125 | Germany |
| Frauenklinik Wetzlar | Wetzlar | Hesse | 35578 | Germany |
| Niels-Stensen-Kliniken | Georgsmarienhütte | Lower Saxony | 49124 | Germany |
| Gynäkologisch-Onkologische Praxis am Pelikanplatz | Hanover | Lower Saxony | 30177 | Germany |
| Klinik f. Frauenheilkunde u. Geburtshilfe | Hanover | Lower Saxony | 30625 | Germany |
| Frauenarzt Bewer und Sternberg Gynäkologie | Hanover | Lower Saxony | 30659 | Germany |
| Gemeinschaftspraxis f. Hämatologie u. Onkologie | Westerstede | Lower Saxony | 26655 | Germany |
| Facharztzentrum am Schloß | Wolfenbüttel | Lower Saxony | 38307 | Germany |
| Evangelisches Krankenhaus Bethedsa Mönchengladbach GmbH | Mönchengladbach | Nordrhein-Westfalens | 41067 | Germany |
| MarienHospital Onkologische Praxis | Bonn | North Rhine-Westphalia | 53115 | Germany |
| Marienhospital Bottrop gGmbH | Bottrop | North Rhine-Westphalia | 46236 | Germany |
| Gemeinschaftspraxis f. Onkologie und Hämatologie | Cologne | North Rhine-Westphalia | 50677 | Germany |
| Kliniken der Stadt Köln g.GmbH | Cologne | North Rhine-Westphalia | 51067 | Germany |
| Universitätsfrauenklinik Düsseldorf | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Universitätsklinikum Essen | Essen | North Rhine-Westphalia | 45147 | Germany |
| PIOH Praxis Internistischer Onkologie und Hämatologie | Frechen | North Rhine-Westphalia | 50226 | Germany |
| Dokusan Gesellschaft für medizinische studien mbH & Co .KG | Herne | North Rhine-Westphalia | 44623 | Germany |
| Helios Klinikum Krefeld | Krefeld | North Rhine-Westphalia | 47805 | Germany |
| Johannes Wesling Klinikum Minden | Minden | North Rhine-Westphalia | 32429 | Germany |
| Marienkrankenhaus/Brustzentrum | Schwerte | North Rhine-Westphalia | 58239 | Germany |
| Praxisnetzwerk Hämatologie/Onkologie | Troisdorf | North Rhine-Westphalia | 53840 | Germany |
| Onkologische Praxis | Velbert | North Rhine-Westphalia | 42551 | Germany |
| Fachinternistische Gemeinschaftspraxis | Witten | North Rhine-Westphalia | 58452 | Germany |
| Hämatologisch-Onkologische Praxis Würselen | Würselen | North Rhine-Westphalia | Germany |
| Schwerpunktpraxis für Hämatologie und Onkologie Hansen/Reeb/Pfitzner-Dempfle/Stehle | Kaiserslautern | Rhineland-Palatinate | 67655 | Germany |
| Universitätsklinikum des Saarlandes | Homburg | Saarland | 66421 | Germany |
| Poliklinik Chemnitz GmbH | Chemnitz | Saxony | 09116 | Germany |
| Onkozentrum Dresden | Dresden | Saxony | 01127 | Germany |
| Onkologische Gemeinschaftspraxis Dresden | Dresden | Saxony | 01307 | Germany |
| Universitätsklinikum Leipzig AöR | Leipzig | Saxony | 04103 | Germany |
| Klinikum Obergöltzsch Rodewisch | Rodewisch | Saxony | 08228 | Germany |
| KKH Torgau, Brustzentrum | Torgau | Saxony | Germany |
| Johanniter-Krankenhaus Genthin-Stendal Klinik für Frauenheilkunde und Geburtshilfe | Stendal | Saxony-Anhalt | 39576 | Germany |
| Christian-Albrecht-Universitäts Kiel | Kiel | Schleswig-Holstein | 24118 | Germany |
| Universitätsklinikum Jena | Jena | Thuringia | 07743 | Germany |
| Gynäkologische Gemeinschaftspraxis | Berlin | 10317 | Germany |
| Charité | Berlin | 12200 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Gynäkologische Praxisklinik Harburg | Hamburg | 21073 | Germany |
| Praxis für Frauen | Ilsede | 31241 | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Haveland Kliniken GmbH | Nauen | 14641 | Germany |
| MVZ Kloster Paradiese GbR | Soest | 59494 | Germany |
| Schwerpunktpraxis Onkologie | Speyer | 67346 | 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 |
Not provided
Not provided