Therapy Management With Nab-Paclitaxel in Daily Routine

NCT02642406 | Unknown DMC

• 1 other identifier: SEN2015-01
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 83

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Assessment of other prognostic characteristics

  A patient remains in the study for a maximum of 36 months or until death, whatever occurs first

• 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

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (83)

Aalen Brustzentrum

Aalen, Baden-Wurttemberg, 73430, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

NCT Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Frauenklinik des Städtischen Klinikums

Karlsruhe, Baden-Wurttemberg, 76133, Germany

Location

St. Vicentius Kliniken gAG

Karlsruhe, Baden-Wurttemberg, 76135, Germany

Location

Ortenau Klinikum Lahr-Ettenheim

Lahr, Baden-Wurttemberg, 77933, Germany

Location

Praxisklinik am Rosengarten

Mannheim, Baden-Wurttemberg, 68165, Germany

Location

Universitätsmedizin Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Paracelsus Krankenhaus Ruit

Ruit, Baden-Wurttemberg, 73760, Germany

Location

Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie

Singen, Baden-Wurttemberg, 78224, Germany

Location

Brustzentrum

Stuttgart, Baden-Wurttemberg, 70176, Germany

Location

Universitätsfrauenklinik Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

GRN-Klinik Weinheim Abteilung für Gynäkologie und Geburtshilfe

Weinheim, Baden-Wurttemberg, 69469, Germany

Location

Klinikum für Frauenheilkunde und Geburtshilfe Esslingen

Esslingen am Neckar, Baden-Württenberg, 73730, Germany

Location

MVZ Amberg

Amberg, Bavaria, 92224, Germany

Location

phase drei Hämato-Onkologischer Studienkreis am Klinikum Aschaffenburg

Aschaffenburg, Bavaria, 63739, Germany

Location

Klinikum Augsburg Frauenklinik

Augsburg, Bavaria, 86156, Germany

Location

Sozialstiftung Bamberg, Klinikum am Bruderwald Klinik für Frauenheilkunde und Geburtshilfe

Bamberg, Bavaria, 96049, Germany

Location

Sozialstiftung Bamberg, Klinikum am Bruderwald Klinik für Frauenheilkunde und Geburtshilfe

Bayreuth, Bavaria, 95445, Germany

Location

Rottal-Inn-Kliniken GmbH

Eggenfelden, Bavaria, 84307, Germany

Location

Universitätsfrauenklinik Erlangen

Erlangen, Bavaria, 91012, Germany

Location

Praxis für Hämatologie Onkologie Palliativmedizin

Landshut, Bavaria, 84028, Germany

Location

Praxisgemeinschaft Dr. med. Steffi Busch

Mühlhausen, Bavaria, 99974, Germany

Location

MOPS Elisenhof MOP-Studiengesellschaft

München, Bavaria, 80335, Germany

Location

Klinikum der Universität München (LMU)

München, Bavaria, 80337, Germany

Location

Praxisgemeinschaft - Frauenärzte am Stadtpark

Nuremberg, Bavaria, 90409, Germany

Location

Caritas-Krankenhaus St. Josef

Regensburg, Bavaria, 93053, Germany

Location

MVZ Weiden GmbH

Weiden, Bavaria, 92637, Germany

Location

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

Würzburg, Bavaria, 97070, Germany

Location

Onkologische Gemeinschaftspraxis

Würzburg, Bavaria, 97080, Germany

Location

Akad. Lehrkrankenhaus der Charité

Ludwigsfelde, Brandenburg, 14947, Germany

Location

Ruppiner Kliniken GmbH

Neuruppin, Brandenburg, 16816, Germany

Location

g.SUND Gynäkologie Kompetenzzentrum

Stralsund, Brandenburg, 18435, Germany

Location

Brustzentrum am Elisabeth-KH Leipzig

Leipzig, Dresden, 04277, Germany

Location

Klinikum Darmstadt

Darmstadt, Hesse, 64283, Germany

Location

Zentrum für Hämatologie und Onkologie Bethanien

Frankfurt am Main, Hesse, 60389, Germany

Location

Agaplesion Markus Krankenhaus

Frankfurt am Main, Hesse, 60431, Germany

Location

MVZ Onkologische Kooperation Harz

Goslar, Hesse, 38643, Germany

Location

Praxis Ammon/Meyer

Göttingen, Hesse, 37073, Germany

Location

Klinikum Kassel GmbH

Kassel, Hesse, 34125, Germany

Location

Frauenklinik Wetzlar

Wetzlar, Hesse, 35578, Germany

Location

Niels-Stensen-Kliniken

Georgsmarienhütte, Lower Saxony, 49124, Germany

Location

Gynäkologisch-Onkologische Praxis am Pelikanplatz

Hanover, Lower Saxony, 30177, Germany

Location

Klinik f. Frauenheilkunde u. Geburtshilfe

Hanover, Lower Saxony, 30625, Germany

Location

Frauenarzt Bewer und Sternberg Gynäkologie

Hanover, Lower Saxony, 30659, Germany

Location

Gemeinschaftspraxis f. Hämatologie u. Onkologie

Westerstede, Lower Saxony, 26655, Germany

Location

Facharztzentrum am Schloß

Wolfenbüttel, Lower Saxony, 38307, Germany

Location

Evangelisches Krankenhaus Bethedsa Mönchengladbach GmbH

Mönchengladbach, Nordrhein-Westfalens, 41067, Germany

Location

MarienHospital Onkologische Praxis

Bonn, North Rhine-Westphalia, 53115, Germany

Location

Marienhospital Bottrop gGmbH

Bottrop, North Rhine-Westphalia, 46236, Germany

Location

Gemeinschaftspraxis f. Onkologie und Hämatologie

Cologne, North Rhine-Westphalia, 50677, Germany

Location

Kliniken der Stadt Köln g.GmbH

Cologne, North Rhine-Westphalia, 51067, Germany

Location

Universitätsfrauenklinik Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

PIOH Praxis Internistischer Onkologie und Hämatologie

Frechen, North Rhine-Westphalia, 50226, Germany

Location

Dokusan Gesellschaft für medizinische studien mbH & Co .KG

Herne, North Rhine-Westphalia, 44623, Germany

Location

Helios Klinikum Krefeld

Krefeld, North Rhine-Westphalia, 47805, Germany

Location

Johannes Wesling Klinikum Minden

Minden, North Rhine-Westphalia, 32429, Germany

Location

Marienkrankenhaus/Brustzentrum

Schwerte, North Rhine-Westphalia, 58239, Germany

Location

Praxisnetzwerk Hämatologie/Onkologie

Troisdorf, North Rhine-Westphalia, 53840, Germany

Location

Onkologische Praxis

Velbert, North Rhine-Westphalia, 42551, Germany

Location

Fachinternistische Gemeinschaftspraxis

Witten, North Rhine-Westphalia, 58452, Germany

Location

Hämatologisch-Onkologische Praxis Würselen

Würselen, North Rhine-Westphalia, Germany

Location

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

Kaiserslautern, Rhineland-Palatinate, 67655, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, Saarland, 66421, Germany

Location

Poliklinik Chemnitz GmbH

Chemnitz, Saxony, 09116, Germany

Location

Onkozentrum Dresden

Dresden, Saxony, 01127, Germany

Location

Onkologische Gemeinschaftspraxis Dresden

Dresden, Saxony, 01307, Germany

Location

Universitätsklinikum Leipzig AöR

Leipzig, Saxony, 04103, Germany

Location

Klinikum Obergöltzsch Rodewisch

Rodewisch, Saxony, 08228, Germany

Location

KKH Torgau, Brustzentrum

Torgau, Saxony, Germany

Location

Johanniter-Krankenhaus Genthin-Stendal Klinik für Frauenheilkunde und Geburtshilfe

Stendal, Saxony-Anhalt, 39576, Germany

Location

Christian-Albrecht-Universitäts Kiel

Kiel, Schleswig-Holstein, 24118, Germany

Location

Universitätsklinikum Jena

Jena, Thuringia, 07743, Germany

Location

Gynäkologische Gemeinschaftspraxis

Berlin, 10317, Germany

Location

Charité

Berlin, 12200, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Gynäkologische Praxisklinik Harburg

Hamburg, 21073, Germany

Location

Praxis für Frauen

Ilsede, 31241, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Haveland Kliniken GmbH

Nauen, 14641, Germany

Location

MVZ Kloster Paradiese GbR

Soest, 59494, Germany

Location

Schwerpunktpraxis Onkologie

Speyer, 67346, Germany

Location

Biospecimen

Retention: NONE RETAINED

Blood samples

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peter Fasching, Prof. Dr.

  Frauenklinik des Universitätsfrauenklinikums Erlangen

  PRINCIPAL INVESTIGATOR

• Hans Joachim Lück, Prof. Dr.

  Gynäkologisch-Onkologische Schwerpunktpraxis am Pelikanplatz

  PRINCIPAL INVESTIGATOR

• Diethelm Wallwiener, Prof. Dr.

  Universitätsklinikum Tübingen Universitäts-Frauenklinik

  STUDY DIRECTOR

• Sara Brucker, Prof. Dr.

  Universitätsklinikum Tübingen Universitäts-Frauenklinik

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 30, 2015
• Study Start: December 1, 2015
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 5, 2020

Record last verified: 2020-01

Locations

DE (83)