Clinical trial NCT01462604: Pilot Study of Patient's Adherence to TYKERB™/TYVERB™ + Capecitabine in Metastatic Breast Cancer
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-10-31
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women older than 18 years old with metastatic or advanced breast cancer

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

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 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.

Primary outcomes:
measure: Subject recruitment and retention in the study
timeFrame: upto week 6
measure: Adherence at Week 3 and Week 6 (MARS-6) and persistence at Week 6
timeFrame: week 3 & 6
measure: Patient knowledge, attitude and beliefs about the regimen
timeFrame: Day 0, Week 3 and Week 6
measure: Acceptability of study procedures and educational materials at Week 6
timeFrame: week 6
Secondary outcomes:
measure: Serious adverse events and adverse events up to 6 weeks
timeFrame: upto week 6
Other outcomes:
Locations:
city: Pokfulam
country: Hong Kong
facility: GSK Investigational Site
city: Shatin
country: Hong Kong
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Karachi
country: Pakistan
facility: GSK Investigational Site
city: Lahore
country: Pakistan
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: