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

This study is not yet open for participant recruitment.
Verified November 2011 by GlaxoSmithKline
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01462604
First received: September 21, 2011
Last updated: November 10, 2011
Last verified: November 2011
History of Changes
  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 Phase
Neoplasms, Breast
 Other: non-drug intervention educational programme
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Subject recruitment and retention in the study [ Time Frame: upto week 6 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Safety during education intervention


Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462604

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Hong Kong
GSK Investigational Site Not yet recruiting
Pokfulam, Hong Kong
Contact: US GSK Clinical Trials Call Center     877-379-3718     GSKClinicalSupportHD@gsk.com    
Contact: EU GSK Clinical Trials Call Center     +44 (0) 20 8990 4466     GSKClinicalSupportHD@gsk.com    
Singapore
GSK Investigational Site Not yet recruiting
Singapore, Singapore, 258500
Contact: US GSK Clinical Trials Call Center     877-379-3718     GSKClinicalSupportHD@gsk.com    
Contact: EU GSK Clinical Trials Call Center     +44 (0) 20 8990 4466     GSKClinicalSupportHD@gsk.com    
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01462604     History of Changes
Other Study ID Numbers: 115553
Study First Received: September 21, 2011
Last Updated: November 10, 2011
Health Authority: Hong Kong: Institutional Review Board
Singapore: Independent Ethics Committee
Philippines: Institutional Review Board
Pakistan: Institutional Review Board
Korea: Institutional Review Board
Spain: Ethics Committee

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Capecitabine
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013