Status:
COMPLETED
Pilot Study of Patient's Adherence to TYKERB™/TYVERB™ + Capecitabine in Metastatic Breast Cancer
Lead Sponsor:
GlaxoSmithKline
Conditions:
Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
This is a 6-week, single arm, pilot study to test the study procedure, educational materials, and measurement instruments for the educational intervention in HER2 overexpressing metastatic or advanced...
Detailed Description
Approximately 60 subjects with HER2+ metastatic or advanced breast cancer who meet the inclusion/exclusion criteria will be enrolled into the study. All subjects will receive education intervention fo...
Eligibility Criteria
Inclusion
- Signed written informed consent;
- Female outpatient aged 18 years or older;
- Subjects must be about to begin their initial treatment with lapatinib + capecitabine for HER2+ metastatic or advanced breast cancer according to physician's clinical judgement as per local prescribing information
- Subjects must be literate, be able to read, understand and write local language.
Exclusion
- Women who is participating in any other interventional clinical trials concurrently;
- Women who is already taking or had taken lapatinib + capecitabine regimen prior to the enrollment;
- Primary lesions that are not of breast origin.
Key Trial Info
Start Date :
November 23 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 24 2013
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01462604
Start Date
November 23 2011
End Date
January 24 2013
Last Update
June 19 2018
Active Locations (7)
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1
GSK Investigational Site
Pokfulam, Hong Kong
2
GSK Investigational Site
Shatin, Hong Kong
3
GSK Investigational Site
Karachi, Pakistan
4
GSK Investigational Site
Lahore, Pakistan, 54600