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

Completed

• Conditions: Cancer
• Interventions: Other: non-drug intervention educational programme

• Registration Number: NCT01462604
• Lead Sponsor: GlaxoSmithKline

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 breast cancer patients

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 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.

Study Timeline

• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-10-27
• Study First Posted: 2011-10-31
• Study Start: 2011-11-23
• Primary Completion: 2013-01-01
• Study Completion: 2013-01-24
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

Inclusion Criteria

1. Signed written informed consent;
2. Female outpatient aged 18 years or older;
3. 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
4. Subjects must be literate, be able to read, understand and write local language.

Exclusion Criteria

1. Women who is participating in any other interventional clinical trials concurrently;
2. Women who is already taking or had taken lapatinib + capecitabine regimen prior to the enrollment;
3. Primary lesions that are not of breast origin.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HER2 overexpressing metastatic or advanced breast cancer pts	non-drug intervention educational programme	-

Primary Outcome Measures

Name	Time	Method
Patient knowledge, attitude and beliefs about the regimen	Day 0, Week 3 and Week 6	Pilot test tools to measure subject knowledge, attitudes, and beliefs about the lapatinib + capecitabine regimen and describe these outcomes
Adherence at Week 3 and Week 6 (MARS-6) and persistence at Week 6	week 3 & 6	Pilot test tools to measure subject adherence to the lapatinib + capecitabine regimen, assess persistence and describe these outcomes
Subject recruitment and retention in the study	upto week 6	Assess the feasibility of recruitment and retention of subjects into the education program
Acceptability of study procedures and educational materials at Week 6	week 6	Evaluate the implementation and acceptability of the education materials and study procedures

Secondary Outcome Measures

Name	Time	Method
Serious adverse events and adverse events up to 6 weeks	upto week 6	Safety during education intervention

Trial Locations

Locations (1)

GSK Investigational Site; 🇸🇬 Singapore, Singapore