Last updated: 11/03/2018 20:47:48
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study.
PH+oeBE - Patterns of care in HER2+ metastatic Breast cancer in large CIS countriEs: A representative, retrospective study in Russian Federation, Ukraine, and Republic of KazakhstanPH+oeBE
GSK study ID
200287
Clinicaltrials.gov ID
Not applicable
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: PH+oeBE - Patterns of care in HER2+ metastatic Breast cancer in large CIS countriEs: A representative, retrospective study in Russian Federation, Ukraine, and Republic of Kazakhstan
Trial description: This study will describe the treatment paradigm used over recent years in the clinical management of HER2+ metastatic breast cancer in CIS. 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 360 female patients diagnosed with HER2-postive metastatic breast cancer in Russia, Kazakhstan and Ukraine. Patients diagnosed with, or who progressed to, metastatic disease between 01 Jan 2010 and 30 Nov 2011 will be included. All patients will be followed until death, loss to follow-up or the end of the study period (30 Nov 2013). 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:
Utilisation of lapatinib plus capecitabine among HER2+ metastatic breast cancer patients (1/2)
Timeframe: from 01 Jan 2010 to 30 Nov 2013
Utilisation of anti-HER2 therapy among HER2+ metastatic breast cancer patients
Timeframe: from 01 Jan 2010 to 30 Nov 2013
Demographic and Clinical Characteristics of HER2+ metastatic breast cancer patients
Timeframe: from 01 Jan 2010 to 30 Nov 2013
Describe the occurrence of brain metastases among HER2+ metastatic breast cancer patients.
Timeframe: from 01 Jan 2010 to 30 Nov 2013
Utilisation of lapatinib plus capecitabine among HER2+ metastatic breast cancer patients (2/2)
Timeframe: from 01 Jan 2010 to 30 Nov 2013
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
360
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
- Female adults aged 18 years or older at diagnosis of, or progression to metastatic breast cancer.
- A diagnosis of breast cancer with documented metastatic disease and with known date of metastatic disease.
- Receiving care for another primary cancer during the study time period
Inclusion and exclusion criteria
Inclusion criteria:
- Female adults aged 18 years or older at diagnosis of, or progression to metastatic breast cancer.
- A diagnosis of breast cancer with documented metastatic disease and with known date of metastatic disease.
- 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:
- Receiving care for another primary cancer during the study time period
Trial location(s)
This study does not involve prospective enrollment of participants.
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
2014-15-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website