Metastatic Breast Cancer Clinical Trial
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.
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.
n/a
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