Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-31 @ 3:28 PM
Study NCT ID:
NCT01462604
Status:
COMPLETED
Last Update Posted:
2018-06-19
First Post:
2011-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Patient's Adherence to TYKERB™/TYVERB™ + Capecitabine in Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-23'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2013-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2011-09-21', 'studyFirstSubmitQcDate': '2011-10-27', 'lastUpdatePostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'Day 0, Week 3 and Week 6', 'description': 'Pilot test tools to measure subject knowledge, attitudes, and beliefs about the lapatinib + capecitabine regimen and describe these outcomes'}, {'measure': 'Acceptability of study procedures and educational materials at Week 6', 'timeFrame': 'week 6', 'description': 'Evaluate the implementation and acceptability of the education materials and study procedures'}], 'secondaryOutcomes': [{'measure': 'Serious adverse events and adverse events up to 6 weeks', 'timeFrame': 'upto week 6', 'description': 'Safety during education intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women older than 18 years old with metastatic or advanced breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed written informed consent;\n2. Female outpatient aged 18 years or older;\n3. 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\n4. Subjects must be literate, be able to read, understand and write local language.\n\nExclusion Criteria:\n\n1. Women who is participating in any other interventional clinical trials concurrently;\n2. Women who is already taking or had taken lapatinib + capecitabine regimen prior to the enrollment;\n3. Primary lesions that are not of breast origin."}, 'identificationModule': {'nctId': 'NCT01462604', 'briefTitle': "Pilot Study of Patient's Adherence to TYKERB™/TYVERB™ + Capecitabine in Metastatic Breast Cancer", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': '115553'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HER2 overexpressing metastatic or advanced breast cancer pts', 'interventionNames': ['Other: non-drug intervention educational programme']}], 'interventions': [{'name': 'non-drug intervention educational programme', 'type': 'OTHER', 'description': 'educational programme', 'armGroupLabels': ['HER2 overexpressing metastatic or advanced breast cancer pts']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pokfulam', 'country': 'Hong Kong', 'facility': 'GSK Investigational Site'}, {'city': 'Shatin', 'country': 'Hong Kong', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}, {'city': 'Karachi', 'country': 'Pakistan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '54600', 'city': 'Lahore', 'country': 'Pakistan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '258500', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '308433', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}