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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02642406
Other study ID # SEN2015-01
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 2015
Est. completion date December 2021

Study information

Verified date January 2020
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1200
Est. completion date December 2021
Est. primary completion date September 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Aalen Brustzentrum Aalen Baden-Württemberg
Germany MVZ Amberg Amberg Bayern
Germany phase drei Hämato-Onkologischer Studienkreis am Klinikum Aschaffenburg Aschaffenburg Bayern
Germany Klinikum Augsburg Frauenklinik Augsburg Bayern
Germany Sozialstiftung Bamberg, Klinikum am Bruderwald Klinik für Frauenheilkunde und Geburtshilfe Bamberg Bayern
Germany Sozialstiftung Bamberg, Klinikum am Bruderwald Klinik für Frauenheilkunde und Geburtshilfe Bayreuth Bayern
Germany Charité Berlin
Germany Gynäkologische Gemeinschaftspraxis Berlin
Germany MarienHospital Onkologische Praxis Bonn Nordrhein-Westfalen
Germany Marienhospital Bottrop gGmbH Bottrop Nordrhein-Westfalen
Germany Poliklinik Chemnitz GmbH Chemnitz Sachsen
Germany Klinikum Darmstadt Darmstadt Hessen
Germany Onkologische Gemeinschaftspraxis Dresden Dresden Sachsen
Germany Onkozentrum Dresden Dresden Sachsen
Germany Universitätsfrauenklinik Düsseldorf Düsseldorf Nordrhein-Westfalen
Germany Rottal-Inn-Kliniken GmbH Eggenfelden Bayern
Germany Universitätsfrauenklinik Erlangen Erlangen Bayern
Germany Universitätsklinikum Essen Essen Nordrhein-Westfalen
Germany Klinikum für Frauenheilkunde und Geburtshilfe Esslingen Esslingen Baden-Württenberg
Germany Agaplesion Markus Krankenhaus Frankfurt Hessen
Germany Zentrum für Hämatologie und Onkologie Bethanien Frankfurt Hessen
Germany PIOH Praxis Internistischer Onkologie und Hämatologie Frechen Nordrhein-Westfalen
Germany Universitätsklinikum Freiburg Freiburg Baden-Württemberg
Germany Niels-Stensen-Kliniken Georgsmarienhütte Niedersachsen
Germany MVZ Onkologische Kooperation Harz Goslar Hessen
Germany Praxis Ammon/Meyer Göttingen Hessen
Germany Gynäkologische Praxisklinik Harburg Hamburg
Germany Universitätsklinikum Hamburg-Eppendorf Hamburg
Germany Frauenarzt Bewer und Sternberg Gynäkologie Hannover Niedersachsen
Germany Gynäkologisch-Onkologische Praxis am Pelikanplatz Hannover Niedersachsen
Germany Klinik f. Frauenheilkunde u. Geburtshilfe Hannover Niedersachsen
Germany NCT Heidelberg Heidelberg Baden-Württemberg
Germany Dokusan Gesellschaft für medizinische studien mbH & Co .KG Herne Nordrhein-Westfalen
Germany Universitätsklinikum des Saarlandes Homburg Saarland
Germany Praxis für Frauen Ilsede
Germany Universitätsklinikum Jena Jena Thüringen
Germany Schwerpunktpraxis für Hämatologie und Onkologie Hansen/Reeb/Pfitzner-Dempfle/Stehle Kaiserslautern Rheinland-Pfalz
Germany Frauenklinik des Städtischen Klinikums Karlsruhe Baden-Württemberg
Germany St. Vicentius Kliniken gAG Karlsruhe Baden-Württemberg
Germany Klinikum Kassel GmbH Kassel Hessen
Germany Christian-Albrecht-Universitäts Kiel Kiel Schleswig-Holstein
Germany Gemeinschaftspraxis f. Onkologie und Hämatologie Köln Nordrhein-Westfalen
Germany Kliniken der Stadt Köln g.GmbH Köln Nordrhein-Westfalen
Germany Helios Klinikum Krefeld Krefeld Nordrhein-Westfalen
Germany Ortenau Klinikum Lahr-Ettenheim Lahr Baden-Württemberg
Germany Praxis für Hämatologie Onkologie Palliativmedizin Landshut Bayern
Germany Brustzentrum am Elisabeth-KH Leipzig Leipzig Dresden
Germany Universitätsklinikum Leipzig AöR Leipzig Sachsen
Germany Akad. Lehrkrankenhaus der Charité Ludwigsfelde Brandenburg
Germany Praxisklinik am Rosengarten Mannheim Baden-Württemberg
Germany Universitätsmedizin Mannheim Mannheim Baden-Württemberg
Germany Johannes Wesling Klinikum Minden Minden Nordrhein-Westfalen
Germany Evangelisches Krankenhaus Bethedsa Mönchengladbach GmbH Mönchengladbach Nordrhein-Westfalens
Germany Praxisgemeinschaft Dr. med. Steffi Busch Mühlhausen Bayern
Germany Klinikum der Universität München (LMU) München Bayern
Germany MOPS Elisenhof MOP-Studiengesellschaft München Bayern
Germany Universitätsklinikum Münster Münster
Germany Haveland Kliniken GmbH Nauen
Germany Ruppiner Kliniken GmbH Neuruppin Brandenburg
Germany Praxisgemeinschaft - Frauenärzte am Stadtpark Nürnberg Bayern
Germany Caritas-Krankenhaus St. Josef Regensburg Bayern
Germany Klinikum Obergöltzsch Rodewisch Rodewisch Sachsen
Germany Paracelsus Krankenhaus Ruit Ruit Baden-Württemberg
Germany Marienkrankenhaus/Brustzentrum Schwerte Nordrhein-Westfalen
Germany Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie Singen Baden-Württemberg
Germany MVZ Kloster Paradiese GbR Soest
Germany Schwerpunktpraxis Onkologie Speyer
Germany Johanniter-Krankenhaus Genthin-Stendal Klinik für Frauenheilkunde und Geburtshilfe Stendal Sachsen-Anhalt
Germany g.SUND Gynäkologie Kompetenzzentrum Stralsund Brandenburg
Germany Brustzentrum Stuttgart Baden-Württemberg
Germany KKH Torgau, Brustzentrum Torgau Sachsen
Germany Praxisnetzwerk Hämatologie/Onkologie Troisdorf Nordrhein-Westfalen
Germany Universitätsfrauenklinik Tübingen Tübingen Baden-Württemberg
Germany Onkologische Praxis Velbert Nordrhein-Westfalen
Germany MVZ Weiden GmbH Weiden Bayern
Germany GRN-Klinik Weinheim Abteilung für Gynäkologie und Geburtshilfe Weinheim Baden-Württemberg
Germany Gemeinschaftspraxis f. Hämatologie u. Onkologie Westerstede Niedersachsen
Germany Frauenklinik Wetzlar Wetzlar Hessen
Germany Fachinternistische Gemeinschaftspraxis Witten Nordrhein-Westfalen
Germany Facharztzentrum am Schloß Wolfenbüttel Niedersachsen
Germany Hämatologisch-Onkologische Praxis Würselen Würselen Nordrhein-Westfalen
Germany Onkologische Gemeinschaftspraxis Würzburg Bayern
Germany Praxis Dr. med. Uwe G. Pöhls und Kollegen Fachärzte für Frauenheilkunde und Geburtshilfe Würzburg Bayern

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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