Neoplasms, Breast Clinical Trial
Official title:
Treatment Options in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer Patients
This study will describe the treatment paradigm used over recent years in the clinical
management of Human Epidermal Growth Factor Receptor 2 (HER2)+ metastatic breast cancer in
Hungary. This information will provide insight into real-world exposure and adherence to
anti-HER2 therapy containing regimens, and improve understanding of the reasons for
discontinuation of this therapy.
This is a retrospective, descriptive, cohort study of approximately 180 female patients
diagnosed with HER2-positive metastatic breast cancer in Hungary. Patients diagnosed with,
or who progressed to, metastatic disease between 01 September 2009 and 01 September 2010
will be included. All patients will be followed until death, loss to follow-up or the end of
the study period (30 September 2012). All data will be collected retrospectively from
patient medical records.
Descriptive statistics of the demographic and clinical characteristics of HER2+ metastatic
breast cancer patients, including sites of metastases, the time from initial breast cancer
diagnosis until diagnosis of metastatic disease, and HER2 testing methodology and status of
HER2 will be described. Further, descriptive statistics of the proportion of HER2+
metastatic breast cancer patients who received anti-HER2 therapy, the sequencing of
different therapies, and the duration of therapies in the metastatic setting will be
analysed. Among the subset of women who receive lapatinib plus capecitabine, descriptive
statistics of the timing of initiation of lapatinib plus capecitabine in the metastatic
treatment pathway, time to treatment discontinuation and time to progression (TTP) on
lapatinib plus capecitabine will be calculated. Further, descriptive statistics of the type
and duration anti-HER2 therapies used prior to initiation of lapatinib plus capecitabine
and, where relevant, after lapatinib+capecitabine will be performed.
n/a
Observational Model: Cohort, Time Perspective: Retrospective
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