Last updated: 11/03/2018 18:14:47
Pilot study of Patient’s adherence to TYKERB™/TYVERB™ + capecitabine in metastatic breast cancer
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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
Trial description: 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
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Subject recruitment and retention in the study
Timeframe: upto week 6
Adherence at Week 3 and Week 6 (MARS-6) and persistence at Week 6
Timeframe: week 3 & 6
Patient knowledge, attitude and beliefs about the regimen
Timeframe: Day 0, Week 3 and Week 6
Acceptability of study procedures and educational materials at Week 6
Timeframe: week 6
Secondary outcomes:
Serious adverse events and adverse events up to 6 weeks
Timeframe: upto week 6
Interventions:
Other: non-drug intervention educational programme
Enrollment:
27
Observational study model:
Case-Only
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Cancer
Product
lapatinib
Collaborators
Not applicable
Study date(s)
November 2011 to January 2013
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- 1. Signed written informed consent;
- 2. Female outpatient aged 18 years or older;
- 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;
Inclusion and exclusion 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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2013-24-01
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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