Treatment Options in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer Patients
Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
Participant gender:
Summary
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.