Treatment Options in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer Patients
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.
Inclusion Criteria:

 -  Female patients aged 18 years or older at diagnosis of, or progression to, metastatic
 breast cancer

 -  Patients with a diagnosis of breast cancer with documented metastatic disease and with
 known date of metastatic disease

 -  Patients with a histologically confirmed HER2+ breast cancer (HER2 testing procedures
 per routine institutional practice; no tissue re-sampling will be performed. If
 conducted at another site, documented results must be available).

 Exclusion Criteria:

 -  Patients receiving care for another primary cancer during the study time period.