Last updated:  11/03/2018 19:09:56
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Treatment options in Human Epidermal Growth Factor Receptor 2 (HER2) positive metastatic breast cancer patients
GSK study ID 
116450
Clinicaltrials.gov ID 
EudraCT ID 
Not applicable
EU CT Number 
Not applicable
Trial status 
                  No longer a GSK study
                
No longer a GSK study
Trial overview
Official title: Treatment options in Human Epidermal Growth Factor Receptor 2 (HER2) positive metastatic breast cancer patients
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Time to progression (TTP) expressed in weeks and months
Timeframe: 2 years
Secondary outcomes: 
Time to discontinuation of lapatinib plus capecitabine, expressed in weeks and months.
Timeframe: 2 years
Interventions:
Enrollment:
1
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
- 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 receiving care for another primary cancer during the study time period.
 
Inclusion and exclusion criteria
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.
 
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
2015-08-07
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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