Pilot Study of Patient's Adherence to TYKERB™/TYVERB™ + Capecitabine in Metastatic Breast Cancer

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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PROACTYVE Pilot:Pilot Study of Patient's Adherence to TYKERB™/TYVERB™+Capecitabine in Metastatic Breast Cancer-Observation of Patient Adherence and Evaluation of Predictive Factors for Patient Adherence After Providing Educational Programme

Conditions
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Cancer

Intervention / Treatment
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* Other: non-drug intervention educational programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HER2 overexpressing metastatic or advanced breast cancer pts<br> | Other: non-drug intervention educational programme<br>* educational programme<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious adverse events and adverse events up to 6 weeks | Safety during education intervention | upto week 6 |