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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01462604
• Other study ID #: 115553
• Status: Completed
• Start date: November 23, 2011
• Est. completion date: January 24, 2013

Study information

• Verified date: June 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 24, 2013
• Est. primary completion date: January 1, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• non-drug intervention educational programme
educational programme

Locations

Country	Name	City	State
Hong Kong	GSK Investigational Site	Pokfulam
Hong Kong	GSK Investigational Site	Shatin
Korea, Republic of	GSK Investigational Site	Seoul
Pakistan	GSK Investigational Site	Karachi
Pakistan	GSK Investigational Site	Lahore
Singapore	GSK Investigational Site	Singapore
Singapore	GSK Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Hong Kong,  Korea, Republic of,  Pakistan,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject recruitment and retention in the study	Assess the feasibility of recruitment and retention of subjects into the education program	upto week 6
Primary	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
Primary	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
Primary	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	Serious adverse events and adverse events up to 6 weeks	Safety during education intervention	upto week 6