Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-03-03 @ 12:41 AM
Study NCT ID:
NCT00555867
Status:
TERMINATED
Last Update Posted:
2011-12-23
First Post:
2007-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient's Anastrozole Compliance to Therapy Programme
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077384', 'term': 'Anastrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4923}}, 'statusModule': {'whyStopped': 'High drop-out rate leads to the conclusion: not enough data will be available to perform proper analyses of data collected after follow-up month 24 visit', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-22', 'studyFirstSubmitDate': '2007-11-07', 'studyFirstSubmitQcDate': '2007-11-07', 'lastUpdatePostDateStruct': {'date': '2011-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compliance rate and persistence rate', 'timeFrame': 'until discontinuation of treatment'}], 'secondaryOutcomes': [{'measure': 'Time to treatment discontinuation', 'timeFrame': 'date of last intake of anastrozole minus date of first prescription of anastrozole + 1'}, {'measure': 'Demographics and other baseline characteristics as well as information regarding concomitant medication, quality of life', 'timeFrame': 'until treatment discontinuation'}, {'measure': 'The percentage number of patients with disease free survival', 'timeFrame': 'after 12 months'}, {'measure': 'Time of disease free survival', 'timeFrame': 'date of recurrence or progression of the tumor minus date of primary breast cancer surgery + 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hormone-receptor positive primary breast cancer', 'compliance', 'Postmenopausal women'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '23378537', 'type': 'DERIVED', 'citation': "Hadji P, Blettner M, Harbeck N, Jackisch C, Luck HJ, Windemuth-Kieselbach C, Zaun S, Kreienberg R. The Patient's Anastrozole Compliance to Therapy (PACT) Program: a randomized, in-practice study on the impact of a standardized information program on persistence and compliance to adjuvant endocrine therapy in postmenopausal women with early breast cancer. Ann Oncol. 2013 Jun;24(6):1505-12. doi: 10.1093/annonc/mds653. Epub 2013 Feb 1."}]}, 'descriptionModule': {'briefSummary': 'Approximately 60 specialised clinics and 420 office based gynaecologists or oncologists will participate in this in practice evaluation program (NIS). The clinic and approximately 7 office based physicians will collaborate within their breast centre networks to conduct this program. A breast centre network should be able to recruit in this program approximately 80 patients (approximately 40 patients per year). It is planned to enroll approximately 4674 patients in this NIS (2337 patients per arm). The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer scheduled for upfront adjuvant endocrine treatment with anastrozole according to the current standard medical procedures.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Postmenopausal women with hormone receptor positive primary breast cancer scheduled for upfront adjuvant endocrine treatment with anastrozole according to the current standard medical practice', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological/cytological confirmed primary diagnosis of early breast cancer\n* Postmenopausal\n* Hormone receptor positive\n\nExclusion Criteria:\n\n* Patients with severe renal function disorders\n* Patients with moderate or severe disorders of hepatic function\n* Concomitant treatment with drugs known to affect sex hormonal status and tamoxifen'}, 'identificationModule': {'nctId': 'NCT00555867', 'acronym': 'PACT', 'briefTitle': "Patient's Anastrozole Compliance to Therapy Programme", 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': "A Randomised in Practice Evaluation of the Influence of Patient's Understanding of Her Disease and Therapy on Persistence and Compliance to Adjuvant Therapy for Post-menopausal Hormone Sensitive Early Breast Cancer", 'orgStudyIdInfo': {'id': '1033GR/0002'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Standard routine care for breast cancer', 'interventionNames': ['Drug: Anastrozole']}, {'label': '2', 'description': 'Standard + Intervention arm: standard routine care for breast cancer and additional information material via post', 'interventionNames': ['Drug: Anastrozole']}], 'interventions': [{'name': 'Anastrozole', 'type': 'DRUG', 'otherNames': ['Arimidex', 'ZD1033'], 'description': 'oral', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'AstraZeneca Germany Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}