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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01462604
First Posted: October 31, 2011
Last Update Posted: July 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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 Intervention
Cancer Other: non-drug intervention educational programme

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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

  • 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

  • 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

  • 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:
  • Serious adverse events and adverse events up to 6 weeks [ Time Frame: upto week 6 ]
    Safety during education intervention


Enrollment: 27
Study Start Date: November 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HER2 overexpressing metastatic or advanced breast cancer pts Other: non-drug intervention educational programme
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01462604     History of Changes
Other Study ID Numbers: 115553
First Submitted: September 21, 2011
First Posted: October 31, 2011
Last Update Posted: July 31, 2013
Last Verified: July 2013

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