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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 breast cancer patients
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 for 6 weeks including education on Day 0, follow-up phone calls on Day 1 and Day 7, reminder phone calls before Week 3 and 6 visit and telephone hot line number.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HER2 overexpressing metastatic or advanced breast cancer pts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-drug intervention educational programme | Other | educational programme |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject recruitment and retention in the study | Assess the feasibility of recruitment and retention of subjects into the education program | upto week 6 |
| Adherence at Week 3 and Week 6 (MARS-6) and persistence at Week 6 | Pilot test tools to measure subject adherence to the lapatinib + capecitabine regimen, assess persistence and describe these outcomes | week 3 & 6 |
| Patient knowledge, attitude and beliefs about the regimen | Pilot test tools to measure subject knowledge, attitudes, and beliefs about the lapatinib + capecitabine regimen and describe these outcomes | Day 0, Week 3 and Week 6 |
| Acceptability of study procedures and educational materials at Week 6 | Evaluate the implementation and acceptability of the education materials and study procedures | week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse events and adverse events up to 6 weeks | Safety during education intervention | upto week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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Women older than 18 years old with metastatic or advanced breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Pokfulam | Hong Kong | ||||
| GSK Investigational Site |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Shatin |
| Hong Kong |
| GSK Investigational Site | Karachi | Pakistan |
| GSK Investigational Site | Lahore | 54600 | Pakistan |
| GSK Investigational Site | Singapore | 258500 | Singapore |
| GSK Investigational Site | Singapore | 308433 | Singapore |
| GSK Investigational Site | Seoul | 120-752 | South Korea |