Know Cancer

or
forgot password

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


Phase 4
18 Years
N/A
Not Enrolling
Female
Neoplasms, Breast

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Subject recruitment and retention in the study

Outcome Description:

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

Outcome Time Frame:

upto week 6

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Hong Kong: Institutional Review Board

Study ID:

115553

NCT ID:

NCT01462604

Start Date:

November 2011

Completion Date:

March 2013

Related Keywords:

  • Neoplasms, Breast
  • Breast Neoplasms
  • Neoplasms

Name

Location