Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT00857012
Status:
COMPLETED
Last Update Posted:
2012-11-12
First Post:
2009-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2313}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-09', 'studyFirstSubmitDate': '2009-03-05', 'studyFirstSubmitQcDate': '2009-03-05', 'lastUpdatePostDateStruct': {'date': '2012-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Assessment of arthralgia scores and patients' compliance within the first year of anastrozole treatment, stratified by upfront and switch therapy as well as assessment of the relationship between compliance and arthralgia scores.", 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Incidence of arthralgia and arthralgia characteristics within the 1st year of anastrozole therapy stratified by upfront and switch therapy and assessment of the relationship of arthralgia incidence and arthralgia characteristics to patients compliance.', 'timeFrame': '12 months'}, {'measure': 'Retrospective assessment of incidence of pre-existing arthralgias before start of anastrozole treatment, stratified by upfront and switch therapy.', 'timeFrame': '12 months'}, {'measure': 'Descriptive assessment of arthralgia therapy and of costs of arthralgia therapy, stratified by upfront and switch therapy.', 'timeFrame': '12 months'}, {'measure': 'Identification of factors influencing and correlating to treatment-emergent arthralgias', 'timeFrame': '12 months'}, {'measure': 'Assessment of safety and tolerability of anastrozole.', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Primary early MCa', 'Arimidex'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '24355487', 'type': 'DERIVED', 'citation': 'Hadji P, Jackisch C, Bolten W, Blettner M, Hindenburg HJ, Klein P, Konig K, Kreienberg R, Rief W, Wallwiener D, Zaun S, Harbeck N. COMPliance and Arthralgia in Clinical Therapy: the COMPACT trial, assessing the incidence of arthralgia, and compliance within the first year of adjuvant anastrozole therapy. Ann Oncol. 2014 Feb;25(2):372-7. doi: 10.1093/annonc/mdt513. Epub 2013 Dec 18.'}]}, 'descriptionModule': {'briefSummary': 'Patients are eligible for inclusion in this NIS if they have taken anastrozole either upfront or following two to three years of tamoxifen treatment ("switch") for at least three and not more than six months prior to offering an individual participation in this program. Treatment should follow local therapy guidelines and standard practice. Treatment decisions for patients participating in this study including assessments or supportive therapy during follow-up visits will also follow guidelines and remain independent of the program.', 'detailedDescription': 'The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer scheduled for adjuvant upfront endocrine treatment with anastrozole or following two to three years of tamoxifen treatment ("switch") according to the current SmPC (Appendix C). Patients will have taken anastrozole for at least three months and not more than six months before the start of the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer receiving adjuvant endocrine treatment with anastrozole upfront or following two to three years of tamoxifen therapy ("switch") according to the current SmPC (Appendix C). Patients will have received anastrozole treatment for at least 3 months and up to 6 months before the start of the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women aged 18 years or older; Postmenopause is defined as Natural menopause with menses \\>1 year ago or Serum FSH (\\> 20 IU/ l), and E2 levels in the postmenopausal range or patients who had bilateral oophorectomy\n* Histologically / cytologically confirmed primary diagnosis of early breast cancer (M0) with hormone sensitive tumour (ER+ve and/or PgR+ve)\n* Patients, who underwent breast cancer surgery and, if appl. radiation therapy and/or neo/adjuvant chemotherapy and have taken adjuvant endocrine treatment with anastrozole (upfront or following two to three years of tamoxifen) min 3 max 6 months\n* In case of a previous therapy with tamoxifen (switch-therapy), duration of tamoxifen treatment for at least two and up to three years.\n\nExclusion Criteria:\n\n* Patients with severe renal function disorders (Creatinine clearance \\< 20 ml/min or Patients with moderate or severe disorders of hepatic function\n* Concomitant treatment with drugs known to affect sex hormonal status and tamoxifen\n* Patients with ductal carcinoma in situ (DCIS) without primary diagnosis of early breast cancer (M0)\n* Evidence of any significant clinical disorder or laboratory finding which in the opinion of the investigator, makes it undesirable for the patient to participate in the program'}, 'identificationModule': {'nctId': 'NCT00857012', 'acronym': 'COMPACT', 'briefTitle': 'Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT): An in Practice Assessment of Arthralgias and Related Costs as Well as Compliance in the First Year of Anastrozole Therapy', 'orgStudyIdInfo': {'id': 'NIS-ODE-ARI-2008/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All patients', 'description': 'treated with Anastrozole as per SPC'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aachen', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Aalen', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.83777, 'lon': 10.0933}}, {'city': 'Ahaus', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.07936, 'lon': 7.01344}}, {'city': 'Albstadt', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.21644, 'lon': 9.02596}}, {'city': 'Altötting', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.22533, 'lon': 12.67665}}, {'city': 'Alzey', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.74657, 'lon': 8.11513}}, 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'Bad Dürkheim', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 49.4618, 'lon': 8.17236}}, {'city': 'Bad Herrenalb', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.79787, 'lon': 8.43617}}, {'city': 'Bad Nauheim', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'city': 'Bad Neuenahr-Ahrweiler', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.54322, 'lon': 7.1113}}, {'city': 'Bad Oeynhausen', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.20699, 'lon': 8.80365}}, {'city': 'Bad Oldesloe', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 53.81167, 'lon': 10.37417}}, {'city': 'Bad Reichenhall', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 47.72947, 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'facility': 'Research Site', 'geoPoint': {'lat': 52.19837, 'lon': 8.58644}}, {'city': 'Celle', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.62264, 'lon': 10.08047}}, {'city': 'Chemnitz', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.8357, 'lon': 12.92922}}, {'city': 'Cloppenburg', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.84754, 'lon': 8.045}}, {'city': 'Coburg', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.25937, 'lon': 10.96384}}, {'city': 'Coesfeld', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.94349, 'lon': 7.16809}}, {'city': 'Cologne', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Dachau', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 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{'city': 'Freising', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.40351, 'lon': 11.74876}}, {'city': 'Freital', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 51.00166, 'lon': 13.6488}}, {'city': 'Freyung', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.80952, 'lon': 13.54768}}, {'city': 'Friedrichshafen', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 47.65689, 'lon': 9.47554}}, {'city': 'Fulda', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 50.55162, 'lon': 9.67518}}, {'city': 'Fürstenfeldbruck', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 48.17904, 'lon': 11.2547}}, {'city': 'Fürstenwalde', 'state': 'Germany', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.36067, 'lon': 14.06185}}, 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