Therapy Management With Nab-Paclitaxel in Daily Routine

NCT ID: NCT02642406

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2021-12-31

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.

Conditions

Metastatic Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Fasching, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Frauenklinik des Universitätsfrauenklinikums Erlangen

Hans Joachim Lück, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Gynäkologisch-Onkologische Schwerpunktpraxis am Pelikanplatz

Diethelm Wallwiener, Prof. Dr.

Role: STUDY_DIRECTOR

Universitätsklinikum Tübingen Universitäts-Frauenklinik

Sara Brucker, Prof. Dr.

Role: STUDY_DIRECTOR

Universitätsklinikum Tübingen Universitäts-Frauenklinik

Locations

Aalen Brustzentrum

Aalen, Baden-Wurttemberg, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

NCT Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Frauenklinik des Städtischen Klinikums

Karlsruhe, Baden-Wurttemberg, Germany

St. Vicentius Kliniken gAG

Karlsruhe, Baden-Wurttemberg, Germany

Ortenau Klinikum Lahr-Ettenheim

Lahr, Baden-Wurttemberg, Germany

Praxisklinik am Rosengarten

Mannheim, Baden-Wurttemberg, Germany

Universitätsmedizin Mannheim

Mannheim, Baden-Wurttemberg, Germany

Paracelsus Krankenhaus Ruit

Ruit, Baden-Wurttemberg, Germany

Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie

Singen, Baden-Wurttemberg, Germany

Brustzentrum

Stuttgart, Baden-Wurttemberg, Germany

Universitätsfrauenklinik Tübingen

Tübingen, Baden-Wurttemberg, Germany

GRN-Klinik Weinheim Abteilung für Gynäkologie und Geburtshilfe

Weinheim, Baden-Wurttemberg, Germany

Klinikum für Frauenheilkunde und Geburtshilfe Esslingen

Esslingen am Neckar, Baden-Württenberg, Germany

MVZ Amberg

Amberg, Bavaria, Germany

phase drei Hämato-Onkologischer Studienkreis am Klinikum Aschaffenburg

Aschaffenburg, Bavaria, Germany

Klinikum Augsburg Frauenklinik

Augsburg, Bavaria, Germany

Sozialstiftung Bamberg, Klinikum am Bruderwald Klinik für Frauenheilkunde und Geburtshilfe

Bamberg, Bavaria, Germany

Sozialstiftung Bamberg, Klinikum am Bruderwald Klinik für Frauenheilkunde und Geburtshilfe

Bayreuth, Bavaria, Germany

Rottal-Inn-Kliniken GmbH

Eggenfelden, Bavaria, Germany

Universitätsfrauenklinik Erlangen

Erlangen, Bavaria, Germany

Praxis für Hämatologie Onkologie Palliativmedizin

Landshut, Bavaria, Germany

Praxisgemeinschaft Dr. med. Steffi Busch

Mühlhausen, Bavaria, Germany

MOPS Elisenhof MOP-Studiengesellschaft

München, Bavaria, Germany

Klinikum der Universität München (LMU)

München, Bavaria, Germany

Praxisgemeinschaft - Frauenärzte am Stadtpark

Nuremberg, Bavaria, Germany

Caritas-Krankenhaus St. Josef

Regensburg, Bavaria, Germany

MVZ Weiden GmbH

Weiden, Bavaria, Germany

Praxis Dr. med. Uwe G. Pöhls und Kollegen Fachärzte für Frauenheilkunde und Geburtshilfe

Würzburg, Bavaria, Germany

Onkologische Gemeinschaftspraxis

Würzburg, Bavaria, Germany

Akad. Lehrkrankenhaus der Charité

Ludwigsfelde, Brandenburg, Germany

Ruppiner Kliniken GmbH

Neuruppin, Brandenburg, Germany

g.SUND Gynäkologie Kompetenzzentrum

Stralsund, Brandenburg, Germany

Brustzentrum am Elisabeth-KH Leipzig

Leipzig, Dresden, Germany

Klinikum Darmstadt

Darmstadt, Hesse, Germany

Zentrum für Hämatologie und Onkologie Bethanien

Frankfurt am Main, Hesse, Germany

Agaplesion Markus Krankenhaus

Frankfurt am Main, Hesse, Germany

MVZ Onkologische Kooperation Harz

Goslar, Hesse, Germany

Praxis Ammon/Meyer

Göttingen, Hesse, Germany

Klinikum Kassel GmbH

Kassel, Hesse, Germany

Frauenklinik Wetzlar

Wetzlar, Hesse, Germany

Niels-Stensen-Kliniken

Georgsmarienhütte, Lower Saxony, Germany

Gynäkologisch-Onkologische Praxis am Pelikanplatz

Hanover, Lower Saxony, Germany

Klinik f. Frauenheilkunde u. Geburtshilfe

Hanover, Lower Saxony, Germany

Frauenarzt Bewer und Sternberg Gynäkologie

Hanover, Lower Saxony, Germany

Gemeinschaftspraxis f. Hämatologie u. Onkologie

Westerstede, Lower Saxony, Germany

Facharztzentrum am Schloß

Wolfenbüttel, Lower Saxony, Germany

Evangelisches Krankenhaus Bethedsa Mönchengladbach GmbH

Mönchengladbach, Nordrhein-Westfalens, Germany

MarienHospital Onkologische Praxis

Bonn, North Rhine-Westphalia, Germany

Marienhospital Bottrop gGmbH

Bottrop, North Rhine-Westphalia, Germany

Gemeinschaftspraxis f. Onkologie und Hämatologie

Cologne, North Rhine-Westphalia, Germany

Kliniken der Stadt Köln g.GmbH

Cologne, North Rhine-Westphalia, Germany

Universitätsfrauenklinik Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

PIOH Praxis Internistischer Onkologie und Hämatologie

Frechen, North Rhine-Westphalia, Germany

Dokusan Gesellschaft für medizinische studien mbH & Co .KG

Herne, North Rhine-Westphalia, Germany

Helios Klinikum Krefeld

Krefeld, North Rhine-Westphalia, Germany

Johannes Wesling Klinikum Minden

Minden, North Rhine-Westphalia, Germany

Marienkrankenhaus/Brustzentrum

Schwerte, North Rhine-Westphalia, Germany

Praxisnetzwerk Hämatologie/Onkologie

Troisdorf, North Rhine-Westphalia, Germany

Onkologische Praxis

Velbert, North Rhine-Westphalia, Germany

Fachinternistische Gemeinschaftspraxis

Witten, North Rhine-Westphalia, Germany

Hämatologisch-Onkologische Praxis Würselen

Würselen, North Rhine-Westphalia, Germany

Schwerpunktpraxis für Hämatologie und Onkologie Hansen/Reeb/Pfitzner-Dempfle/Stehle

Kaiserslautern, Rhineland-Palatinate, Germany

Universitätsklinikum des Saarlandes

Homburg, Saarland, Germany

Poliklinik Chemnitz GmbH

Chemnitz, Saxony, Germany

Onkozentrum Dresden

Dresden, Saxony, Germany

Onkologische Gemeinschaftspraxis Dresden

Dresden, Saxony, Germany

Universitätsklinikum Leipzig AöR

Leipzig, Saxony, Germany

Klinikum Obergöltzsch Rodewisch

Rodewisch, Saxony, Germany

KKH Torgau, Brustzentrum

Torgau, Saxony, Germany

Johanniter-Krankenhaus Genthin-Stendal Klinik für Frauenheilkunde und Geburtshilfe

Stendal, Saxony-Anhalt, Germany

Christian-Albrecht-Universitäts Kiel

Kiel, Schleswig-Holstein, Germany

Universitätsklinikum Jena

Jena, Thuringia, Germany

Gynäkologische Gemeinschaftspraxis

Berlin, , Germany

Charité

Berlin, , Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Gynäkologische Praxisklinik Harburg

Hamburg, , Germany

Praxis für Frauen

Ilsede, , Germany

Universitätsklinikum Münster

Münster, , Germany

Haveland Kliniken GmbH

Nauen, , Germany

MVZ Kloster Paradiese GbR

Soest, , Germany

Schwerpunktpraxis Onkologie

Speyer, , Germany

Countries

Germany

Other Identifiers

SEN2015-01

Identifier Type: -

Identifier Source: org_study_id