Therapy Management With Nab-Paclitaxel in Daily Routine (SERAPHINA)

January 31, 2020 updated by: University Hospital Tuebingen

Safety, Efficacy and Patient Reported Outcomes of Advanced Breast Cancer Patients: Therapy Management With Nab-Paclitaxel in Daily Routine - SERAPHINA

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10317
        • Gynäkologische Gemeinschaftspraxis
      • Berlin, Germany, 12200
        • Charité
      • Hamburg, Germany, 20246
        • Universitatsklinikum Hamburg-Eppendorf
      • Hamburg, Germany, 21073
        • Gynäkologische Praxisklinik Harburg
      • Ilsede, Germany, 31241
        • Praxis für Frauen
      • Münster, Germany, 48149
        • Universitatsklinikum Munster
      • Nauen, Germany, 14641
        • Haveland Kliniken GmbH
      • Soest, Germany, 59494
        • MVZ Kloster Paradiese GbR
      • Speyer, Germany, 67346
        • Schwerpunktpraxis Onkologie
    • Baden-Württemberg
      • Aalen, Baden-Württemberg, Germany, 73430
        • Aalen Brustzentrum
      • Freiburg, Baden-Württemberg, Germany, 79106
        • Universitätsklinikum Freiburg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • NCT Heidelberg
      • Karlsruhe, Baden-Württemberg, Germany, 76133
        • Frauenklinik des Städtischen Klinikums
      • Karlsruhe, Baden-Württemberg, Germany, 76135
        • St. Vicentius Kliniken gAG
      • Lahr, Baden-Württemberg, Germany, 77933
        • Ortenau Klinikum Lahr-Ettenheim
      • Mannheim, Baden-Württemberg, Germany, 68165
        • Praxisklinik am Rosengarten
      • Mannheim, Baden-Württemberg, Germany, 68167
        • Universitätsmedizin Mannheim
      • Ruit, Baden-Württemberg, Germany, 73760
        • Paracelsus Krankenhaus Ruit
      • Singen, Baden-Württemberg, Germany, 78224
        • Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie
      • Stuttgart, Baden-Württemberg, Germany, 70176
        • BrustZentrum
      • Tübingen, Baden-Württemberg, Germany, 72076
        • Universitätsfrauenklinik Tübingen
      • Weinheim, Baden-Württemberg, Germany, 69469
        • GRN-Klinik Weinheim Abteilung für Gynäkologie und Geburtshilfe
    • Baden-Württenberg
      • Esslingen, Baden-Württenberg, Germany, 73730
        • Klinikum für Frauenheilkunde und Geburtshilfe Esslingen
    • Bayern
      • Amberg, Bayern, Germany, 92224
        • MVZ Amberg
      • Aschaffenburg, Bayern, Germany, 63739
        • phase drei Hämato-Onkologischer Studienkreis am Klinikum Aschaffenburg
      • Augsburg, Bayern, Germany, 86156
        • Klinikum Augsburg Frauenklinik
      • Bamberg, Bayern, Germany, 96049
        • Sozialstiftung Bamberg, Klinikum am Bruderwald Klinik für Frauenheilkunde und Geburtshilfe
      • Bayreuth, Bayern, Germany, 95445
        • Sozialstiftung Bamberg, Klinikum am Bruderwald Klinik für Frauenheilkunde und Geburtshilfe
      • Eggenfelden, Bayern, Germany, 84307
        • Rottal-Inn-Kliniken GmbH
      • Erlangen, Bayern, Germany, 91012
        • Universitätsfrauenklinik Erlangen
      • Landshut, Bayern, Germany, 84028
        • Praxis für Hämatologie Onkologie Palliativmedizin
      • Mühlhausen, Bayern, Germany, 99974
        • Praxisgemeinschaft Dr. med. Steffi Busch
      • München, Bayern, Germany, 80335
        • MOPS Elisenhof MOP-Studiengesellschaft
      • München, Bayern, Germany, 80337
        • Klinikum der Universität München (LMU)
      • Nürnberg, Bayern, Germany, 90409
        • Praxisgemeinschaft - Frauenärzte am Stadtpark
      • Regensburg, Bayern, Germany, 93053
        • Caritas-Krankenhaus St. Josef
      • Weiden, Bayern, Germany, 92637
        • MVZ Weiden GmbH
      • Würzburg, Bayern, Germany, 97070
        • Praxis Dr. med. Uwe G. Pöhls und Kollegen Fachärzte für Frauenheilkunde und Geburtshilfe
      • Würzburg, Bayern, Germany, 97080
        • Onkologische Gemeinschaftspraxis
    • Brandenburg
      • Ludwigsfelde, Brandenburg, Germany, 14947
        • Akad. Lehrkrankenhaus der Charité
      • Neuruppin, Brandenburg, Germany, 16816
        • Ruppiner Kliniken GmbH
      • Stralsund, Brandenburg, Germany, 18435
        • G.SUND Gynäkologie Kompetenzzentrum
    • Dresden
      • Leipzig, Dresden, Germany, 04277
        • Brustzentrum am Elisabeth-KH Leipzig
    • Hessen
      • Darmstadt, Hessen, Germany, 64283
        • Klinikum Darmstadt
      • Frankfurt, Hessen, Germany, 60389
        • Zentrum für Hämatologie und Onkologie Bethanien
      • Frankfurt, Hessen, Germany, 60431
        • Agaplesion Markus Krankenhaus
      • Goslar, Hessen, Germany, 38643
        • MVZ Onkologische Kooperation Harz
      • Göttingen, Hessen, Germany, 37073
        • Praxis Ammon/Meyer
      • Kassel, Hessen, Germany, 34125
        • Klinikum Kassel GmbH
      • Wetzlar, Hessen, Germany, 35578
        • Frauenklinik Wetzlar
    • Niedersachsen
      • Georgsmarienhütte, Niedersachsen, Germany, 49124
        • Niels-Stensen-Kliniken
      • Hannover, Niedersachsen, Germany, 30177
        • Gynäkologisch-Onkologische Praxis am Pelikanplatz
      • Hannover, Niedersachsen, Germany, 30625
        • Klinik f. Frauenheilkunde u. Geburtshilfe
      • Hannover, Niedersachsen, Germany, 30659
        • Frauenarzt Bewer und Sternberg Gynäkologie
      • Westerstede, Niedersachsen, Germany, 26655
        • Gemeinschaftspraxis f. Hämatologie u. Onkologie
      • Wolfenbüttel, Niedersachsen, Germany, 38307
        • Facharztzentrum am Schloß
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53115
        • MarienHospital Onkologische Praxis
      • Bottrop, Nordrhein-Westfalen, Germany, 46236
        • Marienhospital Bottrop gGmbH
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
        • Universitätsfrauenklinik Düsseldorf
      • Essen, Nordrhein-Westfalen, Germany, 45147
        • Universitätsklinikum Essen
      • Frechen, Nordrhein-Westfalen, Germany, 50226
        • PIOH Praxis Internistischer Onkologie und Hämatologie
      • Herne, Nordrhein-Westfalen, Germany, 44623
        • Dokusan Gesellschaft für medizinische studien mbH & Co .KG
      • Krefeld, Nordrhein-Westfalen, Germany, 47805
        • Helios Klinikum Krefeld
      • Köln, Nordrhein-Westfalen, Germany, 50677
        • Gemeinschaftspraxis f. Onkologie und Hämatologie
      • Köln, Nordrhein-Westfalen, Germany, 51067
        • Kliniken der Stadt Köln g.GmbH
      • Minden, Nordrhein-Westfalen, Germany, 32429
        • Johannes Wesling Klinikum Minden
      • Schwerte, Nordrhein-Westfalen, Germany, 58239
        • Marienkrankenhaus/Brustzentrum
      • Troisdorf, Nordrhein-Westfalen, Germany, 53840
        • Praxisnetzwerk Hämatologie/Onkologie
      • Velbert, Nordrhein-Westfalen, Germany, 42551
        • Onkologische Praxis
      • Witten, Nordrhein-Westfalen, Germany, 58452
        • Fachinternistische Gemeinschaftspraxis
      • Würselen, Nordrhein-Westfalen, Germany
        • Hämatologisch-Onkologische Praxis Würselen
    • Nordrhein-Westfalens
      • Mönchengladbach, Nordrhein-Westfalens, Germany, 41067
        • Evangelisches Krankenhaus Bethedsa Mönchengladbach GmbH
    • Rheinland-Pfalz
      • Kaiserslautern, Rheinland-Pfalz, Germany, 67655
        • Schwerpunktpraxis für Hämatologie und Onkologie Hansen/Reeb/Pfitzner-Dempfle/Stehle
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Universitätsklinikum des Saarlandes
    • Sachsen
      • Chemnitz, Sachsen, Germany, 09116
        • Poliklinik Chemnitz GmbH
      • Dresden, Sachsen, Germany, 01127
        • Onkozentrum Dresden
      • Dresden, Sachsen, Germany, 01307
        • Onkologische Gemeinschaftspraxis Dresden
      • Leipzig, Sachsen, Germany, 04103
        • Universitätsklinikum Leipzig AöR
      • Rodewisch, Sachsen, Germany, 08228
        • Klinikum Obergöltzsch Rodewisch
      • Torgau, Sachsen, Germany
        • KKH Torgau, Brustzentrum
    • Sachsen-Anhalt
      • Stendal, Sachsen-Anhalt, Germany, 39576
        • Johanniter-Krankenhaus Genthin-Stendal Klinik für Frauenheilkunde und Geburtshilfe
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24118
        • Christian-Albrecht-Universitäts Kiel
    • Thüringen
      • Jena, Thüringen, Germany, 07743
        • Universitatsklinikum Jena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidemiological assessment of progression free survival (PFS) under real life conditions.
Time Frame: A patient remains in the study for a maximum of 36 months or until death, whatever occurs first
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of other prognostic characteristics
Time Frame: A patient remains in the study for a maximum of 36 months or until death, whatever occurs first
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
Influence of age on the prognosis and quality of life.
Time Frame: A patient remains in the study for a maximum of 36 months or until death, whatever occurs first
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
Incidence of adverse events, serious adverse events will be reported.
Time Frame: A patient remains in the study for a maximum of 36 months or until death, whatever occurs first
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
Quality of life (FACT-B -Taxane, Version 4, nab-Paclitaxel specific questions, NCCN-Distress-Thermometer)
Time Frame: A patient remains in the study for a maximum of 36 months or until death, whatever occurs first
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
Influence of breast cancerpatient characteristics on prognosis, adverse event frequencies, quality of life and therapy decision making.
Time Frame: A patient remains in the study for a maximum of 36 months or until death, whatever occurs first
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Peter Fasching, Prof. Dr., Frauenklinik des Universitätsfrauenklinikums Erlangen
  • Principal Investigator: Hans Joachim Lück, Prof. Dr., Gynäkologisch-onkologische Schwerpunktpraxis am Pelikanplatz
  • Study Director: Diethelm Wallwiener, Prof. Dr., Universitätsklinikum Tübingen Universitäts-Frauenklinik
  • Study Director: Sara Brucker, Prof. Dr., Universitätsklinikum Tübingen Universitäts-Frauenklinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

December 9, 2015

First Submitted That Met QC Criteria

December 23, 2015

First Posted (Estimate)

December 30, 2015

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 31, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEN2015-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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