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Metastatic Breast CancerSERAPHINANCT02642406

Therapy Management With Nab-Paclitaxel in Daily Routine

An observational study of Metastatic Breast Cancer, run by University Hospital Tuebingen at 83 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 99 years, women only
Conditions the study is for
Metastatic Breast Cancer
How many people
1,200 participants
Where
83 sitesGermany
Study dates
Dec 2015to Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

83 sites in 1 country.

83 sites in 1 country

Germany83 sites

  • Aalen Brustzentrum

    Aalen, Baden-Wurttemberg, 73430

  • MVZ Amberg

    Amberg, Bavaria, 92224

  • phase drei Hämato-Onkologischer Studienkreis am Klinikum Aschaffenburg

    Aschaffenburg, Bavaria, 63739

  • Klinikum Augsburg Frauenklinik

    Augsburg, Bavaria, 86156

  • Sozialstiftung Bamberg, Klinikum am Bruderwald Klinik für Frauenheilkunde und Geburtshilfe

    Bamberg, Bavaria, 96049

  • Sozialstiftung Bamberg, Klinikum am Bruderwald Klinik für Frauenheilkunde und Geburtshilfe

    Bayreuth, Bavaria, 95445

  • Gynäkologische Gemeinschaftspraxis

    Berlin, 10317

  • Charité

    Berlin, 12200

  • MarienHospital Onkologische Praxis

    Bonn, North Rhine-Westphalia, 53115

  • Marienhospital Bottrop gGmbH

    Bottrop, North Rhine-Westphalia, 46236

  • Poliklinik Chemnitz GmbH

    Chemnitz, Saxony, 09116

  • Gemeinschaftspraxis f. Onkologie und Hämatologie

    Cologne, North Rhine-Westphalia, 50677

  • Kliniken der Stadt Köln g.GmbH

    Cologne, North Rhine-Westphalia, 51067

  • Klinikum Darmstadt

    Darmstadt, Hesse, 64283

  • Onkozentrum Dresden

    Dresden, Saxony, 01127

  • Onkologische Gemeinschaftspraxis Dresden

    Dresden, Saxony, 01307

  • Universitätsfrauenklinik Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40225

  • Rottal-Inn-Kliniken GmbH

    Eggenfelden, Bavaria, 84307

  • Universitätsfrauenklinik Erlangen

    Erlangen, Bavaria, 91012

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

  • Klinikum für Frauenheilkunde und Geburtshilfe Esslingen

    Esslingen am Neckar, Baden-Württenberg, 73730

  • Zentrum für Hämatologie und Onkologie Bethanien

    Frankfurt am Main, Hesse, 60389

  • Agaplesion Markus Krankenhaus

    Frankfurt am Main, Hesse, 60431

  • PIOH Praxis Internistischer Onkologie und Hämatologie

    Frechen, North Rhine-Westphalia, 50226

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Niels-Stensen-Kliniken

    Georgsmarienhütte, Lower Saxony, 49124

  • MVZ Onkologische Kooperation Harz

    Goslar, Hesse, 38643

  • Praxis Ammon/Meyer

    Göttingen, Hesse, 37073

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Gynäkologische Praxisklinik Harburg

    Hamburg, 21073

  • Gynäkologisch-Onkologische Praxis am Pelikanplatz

    Hanover, Lower Saxony, 30177

  • Klinik f. Frauenheilkunde u. Geburtshilfe

    Hanover, Lower Saxony, 30625

  • Frauenarzt Bewer und Sternberg Gynäkologie

    Hanover, Lower Saxony, 30659

  • NCT Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Dokusan Gesellschaft für medizinische studien mbH & Co .KG

    Herne, North Rhine-Westphalia, 44623

  • Universitätsklinikum des Saarlandes

    Homburg, Saarland, 66421

  • Praxis für Frauen

    Ilsede, 31241

  • Universitätsklinikum Jena

    Jena, Thuringia, 07743

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

    Kaiserslautern, Rhineland-Palatinate, 67655

  • Frauenklinik des Städtischen Klinikums

    Karlsruhe, Baden-Wurttemberg, 76133

  • St. Vicentius Kliniken gAG

    Karlsruhe, Baden-Wurttemberg, 76135

  • Klinikum Kassel GmbH

    Kassel, Hesse, 34125

  • Christian-Albrecht-Universitäts Kiel

    Kiel, Schleswig-Holstein, 24118

  • Helios Klinikum Krefeld

    Krefeld, North Rhine-Westphalia, 47805

  • Ortenau Klinikum Lahr-Ettenheim

    Lahr, Baden-Wurttemberg, 77933

  • Praxis für Hämatologie Onkologie Palliativmedizin

    Landshut, Bavaria, 84028

  • Brustzentrum am Elisabeth-KH Leipzig

    Leipzig, Dresden, 04277

  • Universitätsklinikum Leipzig AöR

    Leipzig, Saxony, 04103

  • Akad. Lehrkrankenhaus der Charité

    Ludwigsfelde, Brandenburg, 14947

  • Praxisklinik am Rosengarten

    Mannheim, Baden-Wurttemberg, 68165

  • Universitätsmedizin Mannheim

    Mannheim, Baden-Wurttemberg, 68167

  • Johannes Wesling Klinikum Minden

    Minden, North Rhine-Westphalia, 32429

  • Evangelisches Krankenhaus Bethedsa Mönchengladbach GmbH

    Mönchengladbach, Nordrhein-Westfalens, 41067

  • Praxisgemeinschaft Dr. med. Steffi Busch

    Mühlhausen, Bavaria, 99974

  • MOPS Elisenhof MOP-Studiengesellschaft

    München, Bavaria, 80335

  • Klinikum der Universität München (LMU)

    München, Bavaria, 80337

  • Universitätsklinikum Münster

    Münster, 48149

  • Haveland Kliniken GmbH

    Nauen, 14641

  • Ruppiner Kliniken GmbH

    Neuruppin, Brandenburg, 16816

  • Praxisgemeinschaft - Frauenärzte am Stadtpark

    Nuremberg, Bavaria, 90409

  • Caritas-Krankenhaus St. Josef

    Regensburg, Bavaria, 93053

  • Klinikum Obergöltzsch Rodewisch

    Rodewisch, Saxony, 08228

  • Paracelsus Krankenhaus Ruit

    Ruit, Baden-Wurttemberg, 73760

  • Marienkrankenhaus/Brustzentrum

    Schwerte, North Rhine-Westphalia, 58239

  • Schwerpunktpraxis für Hämatologie und Internistische Onkologie, Gastroenterologie

    Singen, Baden-Wurttemberg, 78224

  • MVZ Kloster Paradiese GbR

    Soest, 59494

  • Schwerpunktpraxis Onkologie

    Speyer, 67346

  • Johanniter-Krankenhaus Genthin-Stendal Klinik für Frauenheilkunde und Geburtshilfe

    Stendal, Saxony-Anhalt, 39576

  • g.SUND Gynäkologie Kompetenzzentrum

    Stralsund, Brandenburg, 18435

  • Brustzentrum

    Stuttgart, Baden-Wurttemberg, 70176

  • KKH Torgau, Brustzentrum

    Torgau, Saxony

  • Praxisnetzwerk Hämatologie/Onkologie

    Troisdorf, North Rhine-Westphalia, 53840

  • Universitätsfrauenklinik Tübingen

    Tübingen, Baden-Wurttemberg, 72076

  • Onkologische Praxis

    Velbert, North Rhine-Westphalia, 42551

  • MVZ Weiden GmbH

    Weiden, Bavaria, 92637

  • GRN-Klinik Weinheim Abteilung für Gynäkologie und Geburtshilfe

    Weinheim, Baden-Wurttemberg, 69469

  • Gemeinschaftspraxis f. Hämatologie u. Onkologie

    Westerstede, Lower Saxony, 26655

  • Frauenklinik Wetzlar

    Wetzlar, Hesse, 35578

  • Fachinternistische Gemeinschaftspraxis

    Witten, North Rhine-Westphalia, 58452

  • Facharztzentrum am Schloß

    Wolfenbüttel, Lower Saxony, 38307

  • Hämatologisch-Onkologische Praxis Würselen

    Würselen, North Rhine-Westphalia

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

    Würzburg, Bavaria, 97070

  • Onkologische Gemeinschaftspraxis

    Würzburg, Bavaria, 97080

Other trials in Germany

About this study

Official title: 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.

Read more

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.

Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)

  1. 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).

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

  2. Influence of age on the prognosis and quality of life.

    Progression free survival, overall survival and quality of life assessed with PRO

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

  3. Incidence of adverse events, serious adverse events will be reported.

    NCI Common Toxicity Criteria Version 4.03

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

  4. 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.

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

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionSep 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02642406
Sponsor's protocol ID
SEN2015-01
Acronym
SERAPHINA
Status last verified
Jan 2020
First submitted
9 Dec 2015
Last updated
5 Feb 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Breast Cancer, run by University Hospital Tuebingen at 83 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02642406.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.

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