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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Cancer

Treatments: Other: non-drug intervention educational programme

Study type: Observational

Funder types: Industry

Identifiers

NCT01462604

115553

Details and patient eligibility

About

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

Full 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.

Enrollment: 27 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

27 participants in 1 patient group

HER2 overexpressing metastatic or advanced breast cancer pts

Treatment:

Other: non-drug intervention educational programme