Clinical trial NCT02642406: Therapy Management With Nab-Paclitaxel in Daily Routine
Official title: Safety, Efficacy and Patient Reported Outcomes of Advanced Breast Cancer Patients: Therapy Management With Nab-Paclitaxel in Daily Routine - SERAPHINA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Breast Cancer
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


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

Primary outcomes:
measure: Epidemiological assessment of progression free survival (PFS) under real life conditions.
timeFrame: A patient remains in the study for a maximum of 36 months or until death, whatever occurs first
Secondary outcomes:
measure: Assessment of other prognostic characteristics
timeFrame: A patient remains in the study for a maximum of 36 months or until death, whatever occurs first
measure: Influence of age on the prognosis and quality of life.
timeFrame: A patient remains in the study for a maximum of 36 months or until death, whatever occurs first
measure: Incidence of adverse events, serious adverse events will be reported.
timeFrame: A patient remains in the study for a maximum of 36 months or until death, whatever occurs first
measure: Quality of life (FACT-B -Taxane, Version 4, nab-Paclitaxel specific questions, NCCN-Distress-Thermometer)
timeFrame: A patient remains in the study for a maximum of 36 months or until death, whatever occurs first
measure: Influence of breast cancerpatient characteristics on prognosis, adverse event frequencies, quality of life and therapy decision making.
timeFrame: A patient remains in the study for a maximum of 36 months or until death, whatever occurs first
Other outcomes:
Locations:
city: Aalen
country: Germany
facility: Aalen Brustzentrum
state: Baden-Württemberg
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
state: Baden-Württemberg
city: Heidelberg
country: Germany
facility: NCT Heidelberg
state: Baden-Württemberg
city: Karlsruhe
country: Germany
facility: Frauenklinik des Städtischen Klinikums
state: Baden-Württemberg
city: Karlsruhe
country: Germany
facility: St. Vicentius Kliniken gAG
state: Baden-Württemberg
city: Lahr
country: Germany
facility: Ortenau Klinikum Lahr-Ettenheim
state: Baden-Württemberg
city: Mannheim
country: Germany
facility: Praxisklinik am Rosengarten
state: Baden-Württemberg
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
state: Baden-Württemberg
city: Ruit
country: Germany
facility: Paracelsus Krankenhaus Ruit
state: Baden-Württemberg
city: Singen
country: Germany
facility: Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie
state: Baden-Württemberg
city: Stuttgart
country: Germany
facility: Brustzentrum
state: Baden-Württemberg
city: Tübingen
country: Germany
facility: Universitätsfrauenklinik Tübingen
state: Baden-Württemberg
city: Weinheim
country: Germany
facility: GRN-Klinik Weinheim Abteilung für Gynäkologie und Geburtshilfe
state: Baden-Württemberg
city: Esslingen
country: Germany
facility: Klinikum für Frauenheilkunde und Geburtshilfe Esslingen
state: Baden-Württenberg
city: Amberg
country: Germany
facility: MVZ Amberg
state: Bayern
city: Aschaffenburg
country: Germany
facility: phase drei Hämato-Onkologischer Studienkreis am Klinikum Aschaffenburg
state: Bayern
city: Augsburg
country: Germany
facility: Klinikum Augsburg Frauenklinik
state: Bayern
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg, Klinikum am Bruderwald Klinik für Frauenheilkunde und Geburtshilfe
state: Bayern
city: Bayreuth
country: Germany
facility: Sozialstiftung Bamberg, Klinikum am Bruderwald Klinik für Frauenheilkunde und Geburtshilfe
state: Bayern
city: Eggenfelden
country: Germany
facility: Rottal-Inn-Kliniken GmbH
state: Bayern
city: Erlangen
country: Germany
facility: Universitätsfrauenklinik Erlangen
state: Bayern
city: Landshut
country: Germany
facility: Praxis für Hämatologie Onkologie Palliativmedizin
state: Bayern
city: Mühlhausen
country: Germany
facility: Praxisgemeinschaft Dr. med. Steffi Busch
state: Bayern
city: München
country: Germany
facility: MOPS Elisenhof MOP-Studiengesellschaft
state: Bayern
city: München
country: Germany
facility: Klinikum der Universität München (LMU)
state: Bayern
city: Nürnberg
country: Germany
facility: Praxisgemeinschaft - Frauenärzte am Stadtpark
state: Bayern
city: Regensburg
country: Germany
facility: Caritas-Krankenhaus St. Josef
state: Bayern
city: Weiden
country: Germany
facility: MVZ Weiden GmbH
state: Bayern
city: Würzburg
country: Germany
facility: Praxis Dr. med. Uwe G. Pöhls und Kollegen Fachärzte für Frauenheilkunde und Geburtshilfe
state: Bayern
city: Würzburg
country: Germany
facility: Onkologische Gemeinschaftspraxis
state: Bayern
city: Ludwigsfelde
country: Germany
facility: Akad. Lehrkrankenhaus der Charité
state: Brandenburg
city: Neuruppin
country: Germany
facility: Ruppiner Kliniken GmbH
state: Brandenburg
city: Stralsund
country: Germany
facility: g.SUND Gynäkologie Kompetenzzentrum
state: Brandenburg
city: Leipzig
country: Germany
facility: Brustzentrum am Elisabeth-KH Leipzig
state: Dresden
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt
state: Hessen
city: Frankfurt
country: Germany
facility: Zentrum für Hämatologie und Onkologie Bethanien
state: Hessen
city: Frankfurt
country: Germany
facility: Agaplesion Markus Krankenhaus
state: Hessen
city: Goslar
country: Germany
facility: MVZ Onkologische Kooperation Harz
state: Hessen
city: Göttingen
country: Germany
facility: Praxis Ammon/Meyer
state: Hessen
city: Kassel
country: Germany
facility: Klinikum Kassel GmbH
state: Hessen
city: Wetzlar
country: Germany
facility: Frauenklinik Wetzlar
state: Hessen
city: Georgsmarienhütte
country: Germany
facility: Niels-Stensen-Kliniken
state: Niedersachsen
city: Hannover
country: Germany
facility: Gynäkologisch-Onkologische Praxis am Pelikanplatz
state: Niedersachsen
city: Hannover
country: Germany
facility: Klinik f. Frauenheilkunde u. Geburtshilfe
state: Niedersachsen
city: Hannover
country: Germany
facility: Frauenarzt Bewer und Sternberg Gynäkologie
state: Niedersachsen
city: Westerstede
country: Germany
facility: Gemeinschaftspraxis f. Hämatologie u. Onkologie
state: Niedersachsen
city: Wolfenbüttel
country: Germany
facility: Facharztzentrum am Schloß
state: Niedersachsen
city: Mönchengladbach
country: Germany
facility: Evangelisches Krankenhaus Bethedsa Mönchengladbach GmbH
state: Nordrhein-Westfalens
city: Bonn
country: Germany
facility: MarienHospital Onkologische Praxis
state: Nordrhein-Westfalen
city: Bottrop
country: Germany
facility: Marienhospital Bottrop gGmbH
state: Nordrhein-Westfalen
city: Düsseldorf
country: Germany
facility: Universitätsfrauenklinik Düsseldorf
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
state: Nordrhein-Westfalen
city: Frechen
country: Germany
facility: PIOH Praxis Internistischer Onkologie und Hämatologie
state: Nordrhein-Westfalen
city: Herne
country: Germany
facility: Dokusan Gesellschaft für medizinische studien mbH & Co .KG
state: Nordrhein-Westfalen
city: Krefeld
country: Germany
facility: Helios Klinikum Krefeld
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Gemeinschaftspraxis f. Onkologie und Hämatologie
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Kliniken der Stadt Köln g.GmbH
state: Nordrhein-Westfalen
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
state: Nordrhein-Westfalen
city: Schwerte
country: Germany
facility: Marienkrankenhaus/Brustzentrum
state: Nordrhein-Westfalen
city: Troisdorf
country: Germany
facility: Praxisnetzwerk Hämatologie/Onkologie
state: Nordrhein-Westfalen
city: Velbert
country: Germany
facility: Onkologische Praxis
state: Nordrhein-Westfalen
city: Witten
country: Germany
facility: Fachinternistische Gemeinschaftspraxis
state: Nordrhein-Westfalen
city: Würselen
country: Germany
facility: Hämatologisch-Onkologische Praxis Würselen
state: Nordrhein-Westfalen
city: Kaiserslautern
country: Germany
facility: Schwerpunktpraxis für Hämatologie und Onkologie Hansen/Reeb/Pfitzner-Dempfle/Stehle
state: Rheinland-Pfalz
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
state: Saarland
city: Stendal
country: Germany
facility: Johanniter-Krankenhaus Genthin-Stendal Klinik für Frauenheilkunde und Geburtshilfe
state: Sachsen-Anhalt
city: Chemnitz
country: Germany
facility: Poliklinik Chemnitz GmbH
state: Sachsen
city: Dresden
country: Germany
facility: Onkozentrum Dresden
state: Sachsen
city: Dresden
country: Germany
facility: Onkologische Gemeinschaftspraxis Dresden
state: Sachsen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR
state: Sachsen
city: Rodewisch
country: Germany
facility: Klinikum Obergöltzsch Rodewisch
state: Sachsen
city: Torgau
country: Germany
facility: KKH Torgau, Brustzentrum
state: Sachsen
city: Kiel
country: Germany
facility: Christian-Albrecht-Universitäts Kiel
state: Schleswig-Holstein
city: Jena
country: Germany
facility: Universitätsklinikum Jena
state: Thüringen
city: Berlin
country: Germany
facility: Gynäkologische Gemeinschaftspraxis
city: Berlin
country: Germany
facility: Charité
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Gynäkologische Praxisklinik Harburg
city: Ilsede
country: Germany
facility: Praxis für Frauen
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Nauen
country: Germany
facility: Haveland Kliniken GmbH
city: Soest
country: Germany
facility: MVZ Kloster Paradiese GbR
city: Speyer
country: Germany
facility: Schwerpunktpraxis Onkologie
Study officials:
affiliation: Frauenklinik des Universitätsfrauenklinikums Erlangen
name: Peter Fasching, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynäkologisch-Onkologische Schwerpunktpraxis am Pelikanplatz
name: Hans Joachim Lück, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Tübingen Universitäts-Frauenklinik
name: Diethelm Wallwiener, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Universitätsklinikum Tübingen Universitäts-Frauenklinik
name: Sara Brucker, Prof. Dr.
role: STUDY_DIRECTOR
References: