Metastatic Breast Cancer Clinical Trial
— SERAPHINAOfficial title:
Safety, Efficacy and Patient Reported Outcomes of Advanced Breast Cancer Patients: Therapy Management With Nab-Paclitaxel in Daily Routine - SERAPHINA
| Verified date | January 2020 |
| Source | University Hospital Tuebingen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Tuebingen |
Germany,
| 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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