Last updated: 03/04/2020 21:00:18
PH+oeBE-Patterns of care in HER2+ metastatic Breast cancer in Europe: A representative, retrospective study in FrancePH+oeBE
GSK study ID
200641
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Cancelled
Cancelled
Trial overview
Official title: PH+oeBE-Patterns of care in HER2+ metastatic Breast cancer in Europe: A representative, retrospective study in France
Trial description: The objective of the PH+oeBE study is to describe the current and real-life treatment patterns for the management of HER2-positive metastatic breast cancer especially among patients receiving lapatinib containing regimens
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Describe the demographic and clinical characteristics of HER2+ metastatic breast cancer patients
Timeframe: January 2011 to July 2014
Utilisation of lapatinib plus aromatase inhibitor among HER2+ metastatic breast cancer patients
Timeframe: January 2011 to July 2014
Utilisation of anti-HER2 therapy among HER2+ metastatic breast cancer patients
Timeframe: January 2011 to July 2014
Utilisation of lapatinib plus capecitabine among HER2+ metastatic breast cancer patients
Timeframe: January 2011 to July 2014
Utilisation of lapatinib in combination with trastuzumab (dual blockade) among HER2+ metastatic breast cancer patients
Timeframe: January 2011 to July 2014
Secondary outcomes:
-
Timeframe: -
Interventions:
Drug: A description of the various types of treatments
Enrollment:
0
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Neoplasms, Breast
Product
lapatinib
Collaborators
Not applicable
Study date(s)
April 2015 to August 2015
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- 1.Female adults aged 18 years or older at diagnosis of, or progression to, metastatic breast cancer.
- 2.A diagnosis of breast cancer with documented metastatic disease and with known date of metastatic disease.
- 1.Receiving care for another primary cancer during the study time period.
Inclusion and exclusion criteria
Inclusion criteria:
- 1.Female adults aged 18 years or older at diagnosis of, or progression to, metastatic breast cancer. 2.A diagnosis of breast cancer with documented metastatic disease and with known date of metastatic disease. 3.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:
- 1.Receiving care for another primary cancer during the study time period.
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Cancelled
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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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