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

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

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

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: non-drug intervention educational programme

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 Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• Hong Kong
  • Pokfulam, Hong Kong
    • GSK Investigational Site
  • Shatin, Hong Kong
    • GSK Investigational Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • GSK Investigational Site
• Pakistan
  • Karachi, Pakistan
    • GSK Investigational Site
  • Lahore, Pakistan, 54600
    • GSK Investigational Site
• Singapore
  • Singapore, Singapore, 258500
    • GSK Investigational Site
  • Singapore, Singapore, 308433
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women older than 18 years old with metastatic or advanced breast cancer

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HER2 overexpressing metastatic or advanced breast cancer pts	Other: non-drug intervention educational programme; educational programme

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: November 23, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 24, 2013

Study Registration Dates

• First Submitted: September 21, 2011
• First Submitted That Met QC Criteria: October 27, 2011
• First Posted (Estimate): October 31, 2011

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 115553