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

GlaxoSmithKline27 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cancer

Interventions

non-drug intervention educational programmeOTHER

educational programme

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

GSK Investigational Site

Pokfulam, Hong Kong

GSK Investigational Site

Shatin, Hong Kong

GSK Investigational Site

Karachi, Pakistan

GSK Investigational Site

Lahore, Pakistan

Outcomes

Primary Outcomes

Subject recruitment and retention in the study

Assess the feasibility of recruitment and retention of subjects into the education program

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: week 6

Secondary Outcomes

Serious adverse events and adverse events up to 6 weeks

Safety during education intervention

Time frame: upto week 6

Data from ClinicalTrials.gov

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