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Therapy Management With Nab-Paclitaxel in Daily Routine

NCT02642406 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2020-02-05

No results posted yet for this study

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

Sponsors & Collaborators

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Peter Fasching, Prof. Dr. · Frauenklinik des Universitätsfrauenklinikums Erlangen

  • Hans Joachim Lück, Prof. Dr. · Gynäkologisch-Onkologische Schwerpunktpraxis am Pelikanplatz

  • Diethelm Wallwiener, Prof. Dr. · Universitätsklinikum Tübingen Universitäts-Frauenklinik

  • Sara Brucker, Prof. Dr. · Universitätsklinikum Tübingen Universitäts-Frauenklinik

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2021-09-30
Completion
2021-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02642406 on ClinicalTrials.gov