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

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ClinicalTrials.gov Identifier: NCT01462604
Recruitment Status : Completed
First Posted : October 31, 2011
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

Condition or disease Intervention/treatment
Cancer 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
Actual Enrollment : 27 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : November 23, 2011
Actual Primary Completion Date : January 1, 2013
Actual Study Completion Date : January 24, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

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



Primary Outcome Measures :
  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 Outcome Measures :
  1. Serious adverse events and adverse events up to 6 weeks [ Time Frame: upto week 6 ]
    Safety during education intervention



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women older than 18 years old with metastatic or advanced breast cancer
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01462604


Locations
Hong Kong
GSK Investigational Site
Pokfulam, Hong Kong
GSK Investigational Site
Shatin, Hong Kong
Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 120-752
Pakistan
GSK Investigational Site
Karachi, Pakistan
GSK Investigational Site
Lahore, Pakistan, 54600
Singapore
GSK Investigational Site
Singapore, Singapore, 258500
GSK Investigational Site
Singapore, Singapore, 308433
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01462604     History of Changes
Other Study ID Numbers: 115553
First Posted: October 31, 2011    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents