Clinical trial · Observational
Pilot Study of Patient's Adherence to TYKERB™/TYVERB™ + Capecitabine in Metastatic Breast Cancer
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
NCT01462604CI-TRIAL-00033360completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| non-drug intervention educational programme | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HER2 overexpressing metastatic or advanced breast cancer pts
- interventionNames
- Other: non-drug intervention educational programme
Primary outcomes (4)
- measure
- Subject recruitment and retention in the study
- timeFrame
- upto week 6
- description
- Assess the feasibility of recruitment and retention of subjects into the education program
- measure
- Adherence at Week 3 and Week 6 (MARS-6) and persistence at Week 6
- timeFrame
- week 3 & 6
- description
- Pilot test tools to measure subject adherence to the lapatinib + capecitabine regimen, assess persistence and describe these outcomes
- measure
- Patient knowledge, attitude and beliefs about the regimen
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.