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Completed

NCT Number: NCT01462604

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

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

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

GSK Investigational Site, Pokfulam, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

non-drug intervention educational programme

Other

educational programme

Primary outcomes

  1. Subject recruitment and retention in the study

    Time frame: upto week 6

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

  2. Adherence at Week 3 and Week 6 (MARS-6) and persistence at Week 6

    Time frame: week 3 & 6

    Pilot test tools to measure subject adherence to the lapatinib + capecitabine regimen, assess persistence and describe these outcomes

  3. Patient knowledge, attitude and beliefs about the regimen

    Time frame: Day 0, Week 3 and Week 6

    Pilot test tools to measure subject knowledge, attitudes, and beliefs about the lapatinib + capecitabine regimen and describe these outcomes

  4. Acceptability of study procedures and educational materials at Week 6

    Time frame: week 6

    Evaluate the implementation and acceptability of the education materials and study procedures

Secondary outcomes

  1. Serious adverse events and adverse events up to 6 weeks

    Time frame: upto week 6

    Safety during education intervention

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 31, 2011
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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