Therapy Management With Nab-Paclitaxel in Daily Routine
- Conditions
- Metastatic Breast Cancer
- Registration Number
- NCT02642406
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1200
- Patients with metastatic breast cancer in which a therapy with nab-paclitaxel was indicated by the treating physician
- Treatment of nab-Paclitaxel must either have not been started yet, or first application of nab-Paclitaxel was not prior to 21 days before study entry
- Female patients, age ≥18 years
- Invasive breast cancer (irrespective of status of BC, e.g. TNM, receptor status etc.)
- Metastatic or locally advanced, inoperable disease proven by clinical measures (i.e. standard imaging)
- Patients scheduled for nab-Paclitaxel treatment in daily routine before screening
- Patients, who are able and willing to sign the informed consent form
- Patient is currently enrolled, or will enroll in an interventional clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Epidemiological assessment of progression free survival (PFS) under real life conditions. A patient remains in the study for a maximum of 36 months or until death, whatever occurs first PFS defined as the time to the first progression or death after therapy start of nab-Paclitaxel.
- Secondary Outcome Measures
Name Time Method Influence of age on the prognosis and quality of life. A patient remains in the study for a maximum of 36 months or until death, whatever occurs first Progression free survival, overall survival and quality of life assessed with PRO
Assessment of other prognostic characteristics A patient remains in the study for a maximum of 36 months or until death, whatever occurs first 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).
Incidence of adverse events, serious adverse events will be reported. A patient remains in the study for a maximum of 36 months or until death, whatever occurs first NCI Common Toxicity Criteria Version 4.03
Influence of breast cancerpatient characteristics 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 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.
Quality of life (FACT-B -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 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.
Trial Locations
- Locations (82)
Klinikum Augsburg Frauenklinik
🇩🇪Augsburg, Bayern, Germany
Sozialstiftung Bamberg, Klinikum am Bruderwald Klinik für Frauenheilkunde und Geburtshilfe
🇩🇪Bayreuth, Bayern, Germany
MOPS Elisenhof MOP-Studiengesellschaft
🇩🇪München, Bayern, Germany
Onkologische Gemeinschaftspraxis
🇩🇪Würzburg, Bayern, Germany
Klinikum Darmstadt
🇩🇪Darmstadt, Hessen, Germany
Praxis Ammon/Meyer
🇩🇪Göttingen, Hessen, Germany
Praxisklinik am Rosengarten
🇩🇪Mannheim, Baden-Württemberg, Germany
Klinikum für Frauenheilkunde und Geburtshilfe Esslingen
🇩🇪Esslingen, Baden-Württenberg, Germany
Caritas-Krankenhaus St. Josef
🇩🇪Regensburg, Bayern, Germany
MVZ Weiden GmbH
🇩🇪Weiden, Bayern, Germany
Zentrum für Hämatologie und Onkologie Bethanien
🇩🇪Frankfurt, Hessen, Germany
Paracelsus Krankenhaus Ruit
🇩🇪Ruit, Baden-Württemberg, Germany
Frauenklinik des Städtischen Klinikums
🇩🇪Karlsruhe, Baden-Württemberg, Germany
St. Vicentius Kliniken gAG
🇩🇪Karlsruhe, Baden-Württemberg, Germany
phase drei Hämato-Onkologischer Studienkreis am Klinikum Aschaffenburg
🇩🇪Aschaffenburg, Bayern, Germany
Rottal-Inn-Kliniken GmbH
🇩🇪Eggenfelden, Bayern, Germany
Praxis für Hämatologie Onkologie Palliativmedizin
🇩🇪Landshut, Bayern, Germany
Klinikum der Universität München (LMU)
🇩🇪München, Bayern, Germany
NCT Heidelberg
🇩🇪Heidelberg, Baden-Württemberg, Germany
Universitätsfrauenklinik Tübingen
🇩🇪Tübingen, Baden-Württemberg, Germany
Akad. Lehrkrankenhaus der Charité
🇩🇪Ludwigsfelde, Brandenburg, Germany
MVZ Amberg
🇩🇪Amberg, Bayern, Germany
Praxisgemeinschaft Dr. med. Steffi Busch
🇩🇪Mühlhausen, Bayern, Germany
Praxis Dr. med. Uwe G. Pöhls und Kollegen Fachärzte für Frauenheilkunde und Geburtshilfe
🇩🇪Würzburg, Bayern, Germany
g.SUND Gynäkologie Kompetenzzentrum
🇩🇪Stralsund, Brandenburg, Germany
Universitätsfrauenklinik Düsseldorf
🇩🇪Düsseldorf, Nordrhein-Westfalen, Germany
Universitätsklinikum Essen
🇩🇪Essen, Nordrhein-Westfalen, Germany
Helios Klinikum Krefeld
🇩🇪Krefeld, Nordrhein-Westfalen, Germany
Schwerpunktpraxis für Hämatologie und Onkologie Hansen/Reeb/Pfitzner-Dempfle/Stehle
🇩🇪Kaiserslautern, Rheinland-Pfalz, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Haveland Kliniken GmbH
🇩🇪Nauen, Germany
Aalen Brustzentrum
🇩🇪Aalen, Baden-Württemberg, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Baden-Württemberg, Germany
Ortenau Klinikum Lahr-Ettenheim
🇩🇪Lahr, Baden-Württemberg, Germany
Universitätsmedizin Mannheim
🇩🇪Mannheim, Baden-Württemberg, Germany
Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie
🇩🇪Singen, Baden-Württemberg, Germany
Brustzentrum
🇩🇪Stuttgart, Baden-Württemberg, Germany
Christian-Albrecht-Universitäts Kiel
🇩🇪Kiel, Schleswig-Holstein, Germany
Gynäkologische Praxisklinik Harburg
🇩🇪Hamburg, Germany
Universitätsfrauenklinik Erlangen
🇩🇪Erlangen, Bayern, Germany
Praxisgemeinschaft - Frauenärzte am Stadtpark
🇩🇪Nürnberg, Bayern, Germany
Brustzentrum am Elisabeth-KH Leipzig
🇩🇪Leipzig, Dresden, Germany
MVZ Onkologische Kooperation Harz
🇩🇪Goslar, Hessen, Germany
Niels-Stensen-Kliniken
🇩🇪Georgsmarienhütte, Niedersachsen, Germany
Gynäkologisch-Onkologische Praxis am Pelikanplatz
🇩🇪Hannover, Niedersachsen, Germany
Frauenarzt Bewer und Sternberg Gynäkologie
🇩🇪Hannover, Niedersachsen, Germany
Dokusan Gesellschaft für medizinische studien mbH & Co .KG
🇩🇪Herne, Nordrhein-Westfalen, Germany
Praxisnetzwerk Hämatologie/Onkologie
🇩🇪Troisdorf, Nordrhein-Westfalen, Germany
GRN-Klinik Weinheim Abteilung für Gynäkologie und Geburtshilfe
🇩🇪Weinheim, Baden-Württemberg, Germany
Ruppiner Kliniken GmbH
🇩🇪Neuruppin, Brandenburg, Germany
Universitätsklinikum des Saarlandes
🇩🇪Homburg, Saarland, Germany
Agaplesion Markus Krankenhaus
🇩🇪Frankfurt, Hessen, Germany
Frauenklinik Wetzlar
🇩🇪Wetzlar, Hessen, Germany
MarienHospital Onkologische Praxis
🇩🇪Bonn, Nordrhein-Westfalen, Germany
PIOH Praxis Internistischer Onkologie und Hämatologie
🇩🇪Frechen, Nordrhein-Westfalen, Germany
Fachinternistische Gemeinschaftspraxis
🇩🇪Witten, Nordrhein-Westfalen, Germany
Hämatologisch-Onkologische Praxis Würselen
🇩🇪Würselen, Nordrhein-Westfalen, Germany
Poliklinik Chemnitz GmbH
🇩🇪Chemnitz, Sachsen, Germany
Charité
🇩🇪Berlin, Germany
Marienhospital Bottrop gGmbH
🇩🇪Bottrop, Nordrhein-Westfalen, Germany
Klinikum Kassel GmbH
🇩🇪Kassel, Hessen, Germany
Gemeinschaftspraxis f. Hämatologie u. Onkologie
🇩🇪Westerstede, Niedersachsen, Germany
Facharztzentrum am Schloß
🇩🇪Wolfenbüttel, Niedersachsen, Germany
Kliniken der Stadt Köln g.GmbH
🇩🇪Köln, Nordrhein-Westfalen, Germany
Marienkrankenhaus/Brustzentrum
🇩🇪Schwerte, Nordrhein-Westfalen, Germany
Onkologische Praxis
🇩🇪Velbert, Nordrhein-Westfalen, Germany
Johanniter-Krankenhaus Genthin-Stendal Klinik für Frauenheilkunde und Geburtshilfe
🇩🇪Stendal, Sachsen-Anhalt, Germany
Universitätsklinikum Leipzig AöR
🇩🇪Leipzig, Sachsen, Germany
Klinikum Obergöltzsch Rodewisch
🇩🇪Rodewisch, Sachsen, Germany
KKH Torgau, Brustzentrum
🇩🇪Torgau, Sachsen, Germany
Praxis für Frauen
🇩🇪Ilsede, Germany
Schwerpunktpraxis Onkologie
🇩🇪Speyer, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Klinik f. Frauenheilkunde u. Geburtshilfe
🇩🇪Hannover, Niedersachsen, Germany
Evangelisches Krankenhaus Bethedsa Mönchengladbach GmbH
🇩🇪Mönchengladbach, Nordrhein-Westfalens, Germany
Gemeinschaftspraxis f. Onkologie und Hämatologie
🇩🇪Köln, Nordrhein-Westfalen, Germany
Johannes Wesling Klinikum Minden
🇩🇪Minden, Nordrhein-Westfalen, Germany
Onkologische Gemeinschaftspraxis Dresden
🇩🇪Dresden, Sachsen, Germany
Universitätsklinikum Jena
🇩🇪Jena, Thüringen, Germany
MVZ Kloster Paradiese GbR
🇩🇪Soest, Germany
Onkozentrum Dresden
🇩🇪Dresden, Sachsen, Germany
Gynäkologische Gemeinschaftspraxis
🇩🇪Berlin, Germany