An observational study in Neoplasms, Breast, sponsored by GlaxoSmithKline. Completed at 1 site in Hungary. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-10.
Sponsored by GlaxoSmithKline · Observational
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.
12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 1 is below the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.
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It is planned to capture data on approximately 180 patients with HER2-positive metastatic breast cancer in about 20 medical centres 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).
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Exclusion Criteria:
HER2+ metastatic breast cancer patients treated with lapatinib plus capecitabine
Drug: Lapatinib plus capecitabine
Drug pages: Lapatinib · Capecitabine
Lapatinib plus capecitabine
Time to progression (TTP) expressed in weeks and months
Time frame: 2 years
Time to discontinuation of lapatinib plus capecitabine, expressed in weeks and months.
Discontinuation will be measured from the initiation of lapatinib plus capecitabine to the date of discontinuation of this regimen due to any reason. Patients still responding to lapatinib plus capecitabine at the end of the Follow up Period will be censored at the date of the last follow-up contact.
Time frame: 2 years
The record gives a start of Aug 2014, a primary completion of Jul 2015 and a completion of Jul 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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