Last updated: 11/03/2018 22:27:51
HO-14-15662 - Tykerb/Tyverb Efficacy and Sequence of Treatment in HER2+ metastatic Breast Cancer (TESTER)
GSK study ID
203045
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: HO-14-15662 - Tykerb/Tyverb Efficacy and Sequence of Treatment in HER2+ metastatic Breast Cancer (TESTER)
Trial description: The aim of this retrospective study is to examine patient characteristics, treatment patterns, and outcomes including progression free survival (PFS), overall survival (OS), and best overall response in a sample of patients diagnosed with human epidermal growth factor receptor 2-postive (HER2+) metastatic breast cancer (MBC) with a record of lapatinib or T-DM1.This study also aims to examine rates of development of brain metastases and the extent to which lapatinib is prematurely discontinued due to rash and diarrhea among patients with HER2+ MBC treated in community oncology practices.TYKERB/TYVERB are registered trademarks of the GlaxoSmithKline group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Progression-free survival
Timeframe: Up to 6 years
Overall survival treatment response
Timeframe: Up to 6 years
Treatment patterns
Timeframe: Up to 6 years
Secondary outcomes:
Frequency and severity of diarrhea and rash
Timeframe: Up to 6 years
Association of diarrhea and rash with early discontinuation of lapatinib
Timeframe: Up to 6 years
Rate of occurrence of brain metastases
Timeframe: Up to 6 years
Interventions:
Drug: lapatinib
Enrollment:
1
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)
January 2015 to May 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
none
- Diagnosis of malignant neoplasm of the female breast
- Stage IV breast cancer
- Patients with documentation of negative HER2 status
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of malignant neoplasm of the female breast
- Stage IV breast cancer
- Age ≥18 years at time of Stage IV breast cancer diagnosis
- Received a third or later line of therapy as per protocol section 3.3.2
- Initiated third line therapy on or after January 1, 2008
Exclusion criteria:
- Patients with documentation of negative HER2 status
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2015-30-05
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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