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

NCT01462604 | Completed

• 1 other identifier: 115553
• Study Type: observational
• Target: 27
• Locations: 4 countries
• Sites: 7

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Serious adverse events and adverse events up to 6 weeks

  upto week 6

Study Arms (1)

HER2 overexpressing metastatic or advanced breast cancer pts

Other: non-drug intervention educational programme

Interventions

non-drug intervention educational programme OTHER

educational programme

HER2 overexpressing metastatic or advanced breast cancer pts

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (7)

GSK Investigational Site

Pokfulam, Hong Kong

Location

GSK Investigational Site

Shatin, Hong Kong

Location

GSK Investigational Site

Karachi, Pakistan

Location

GSK Investigational Site

Lahore, 54600, Pakistan

Location

GSK Investigational Site

Singapore, 258500, Singapore

Location

GSK Investigational Site

Singapore, 308433, Singapore

Location

GSK Investigational Site

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: October 31, 2011
• Study Start: November 23, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 24, 2013
• Last Updated: June 19, 2018

Record last verified: 2018-06

Locations

PA (2); KR (1); SG (2); HK (2)