Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-31 @ 3:11 PM
Study NCT ID:
NCT00369850
Status:
COMPLETED
Last Update Posted:
2012-07-27
First Post:
2006-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Density and Bone Loss in Postmenopausal Women With Breast Cancer Receiving Treatment in Clinical Trial IBCSG-1-98
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010024', 'term': 'Osteoporosis'}], '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': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015502', 'term': 'Absorptiometry, Photon'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 458}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-26', 'studyFirstSubmitDate': '2006-08-24', 'studyFirstSubmitQcDate': '2006-08-24', 'lastUpdatePostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative percent change of bone mineral density (BMD) form baseline to after 2, 3, 4, or 5 years of treatment on protocol IBCSG-1-98', 'timeFrame': '5 years after randomisation to BIG 1-98'}, {'measure': 'Recovery of BMD at 1 year after the completion of treatment on protocol IBCSG-1-98', 'timeFrame': '6 years after randomisation to BIG 1-98'}, {'measure': 'Proportion of patients with BMD below the absolute threshold value for osteoporosis', 'timeFrame': '5 years after randomisation to BIG 1-98'}, {'measure': 'Relative percent change in markers of bone resorption from baseline to after 2, 3, 4, or 5 years of treatment on protocol IBCSG-1-98', 'timeFrame': '5 years after randomisation to BIG 1-98'}, {'measure': 'Recovery of the markers of bone resorption at 1 year after the completion of treatment on protocol IBCSG-1-98', 'timeFrame': '6 years after randomisation to BIG 1-98'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['osteoporosis', 'stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer'], 'conditions': ['Breast Cancer', 'Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '24487691', 'type': 'DERIVED', 'citation': 'Decensi A, Sun Z, Guerrieri-Gonzaga A, Thurlimann B, McIntosh C, Tondini C, Monnier A, Campone M, Debled M, Schonenberger A, Zaman K, Johansson H, Price KN, Gelber RD, Goldhirsch A, Coates AS, Aebi S. Bone mineral density and circulating biomarkers in the BIG 1-98 trial comparing adjuvant letrozole, tamoxifen and their sequences. Breast Cancer Res Treat. 2014 Apr;144(2):321-9. doi: 10.1007/s10549-014-2849-2. Epub 2014 Feb 1.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Diagnostic procedures, such as bone mineral density testing and x-ray, help measure bone loss in women receiving treatment for breast cancer. The test results may help doctors plan better treatment.\n\nPURPOSE: This phase III trial is studying bone density and bone loss in postmenopausal women with breast cancer receiving treatment in clinical trial IBCSG-1-98.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the effects on bone mineral density (BMD) in the L2-L4 (posterio-anterior) region of the spine and hip by assessing bone density in postmenopausal women with breast cancer receiving treatment on protocol IBCSG-1-98.\n* Compare the incidence of radiological gross changes and fractures identified from spine x-rays (T4-L4) in these patients (in groups 1 and 2).\n* Use longitudinal BMD measurements to estimate a linear rate of bone loss based on mixed effect models.\n* Identify serum markers for bone loss to determine how they correlate with osteoporosis, microfractures, clinical fractures, and breast cancer-related bone events.\n\nOUTLINE: This is a multicenter study and a substudy of protocol IBCSG-1-98. Patients are assigned to 1 of 3 groups according to the length of treatment they have undergone on protocol IBCSG-1-98.\n\n* Group 1 (prior to or at the end of the second year of treatment on protocol IBCSG-1-98): Patients undergo bone mineral density (BMD) testing of the L2-L4 spine and hip at baseline and years 1, 2, 3, and 4 from baseline. They also undergo x-rays of the T4-L4 spine at baseline and years 1, 3, and 4 from baseline.\n* Group 2 (after 2 years but before the end of the third year of treatment on protocol IBCSG-1-98): Patients undergo BMD testing of the L2-L4 spine and hip at baseline and years 1, 2, and 3 from baseline. They also undergo x-rays of the T4-L4 spine at baseline and years 2 and 3 from baseline.\n* Group 3 (after 3 years but before the end of the fifth year of treatment on protocol IBCSG-1-98): Patients undergo BMD testing of the L2-L4 spine and hip at baseline and years 1 and 2 from baseline (for patients in 4th year of treatment) or year 1 from baseline (for patients in 5th year of treatment).\n\nPatients undergo blood collection at baseline and periodically during study for biomarker correlative study.\n\nPROJECTED ACCRUAL: A total of 660 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Diagnosis of breast cancer\n\n * Resected disease\n* Enrolled on protocol IBCSG-1-98\n\n * Receiving adjuvant endocrine therapy comprising 1 of the following regimens:\n\n * Letrozole\n * Tamoxifen\n * Letrozole after 2 years of tamoxifen\n * Tamoxifen after 2 years of letrozole\n * Not yet completed 5 years of treatment\n* No breast cancer recurrence or second primary cancer\n* No known, symptomatic bone disease, including osteomalacia or osteogenesis imperfecta\n* No prior registration to protocol IBCSG-1-98 Bone Mineral Density substudy\n* Hormone receptor status:\n\n * Estrogen receptor-positive and/or progesterone receptor-positive tumor\n\nPATIENT CHARACTERISTICS:\n\n* Female\n* Postmenopausal\n* No uncontrolled thyroid or parathyroid disease, Cushing's disease, or other pituitary diseases\n* No malabsorption syndrome or clinically relevant vitamin D deficiency\n* No patients for whom the bone density determination is impossible\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* More than 1 year since prior and no concurrent anticonvulsants\n* More than 6 weeks since prior and no concurrent corticosteroids (at doses \\> the equivalent of 5 mg/day prednisone) for \\> 2 weeks total\n* No prior or concurrent sodium fluoride (at daily doses ≥ 5 mg/day) for \\> 1 month\n* More than 12 months since prior and no concurrent anabolic steroids\n* More than 6 months since prior treatment, either investigational or not, for the prevention of osteoporosis (excluding calcium or cholecalciferol \\[vitamin D\\])\n* No concurrent raloxifene\n* Concurrent therapeutic intervention for osteoporosis comprising bisphosphonates allowed\n* Concurrent warfarin allowed provided it is given for ≤ 4 weeks"}, 'identificationModule': {'nctId': 'NCT00369850', 'briefTitle': 'Bone Density and Bone Loss in Postmenopausal Women With Breast Cancer Receiving Treatment in Clinical Trial IBCSG-1-98', 'organization': {'class': 'NETWORK', 'fullName': 'ETOP IBCSG Partners Foundation'}, 'officialTitle': 'Investigating Bone Density and Bone Loss Without Baseline Information', 'orgStudyIdInfo': {'id': 'CDR0000482381'}, 'secondaryIdInfos': [{'id': 'IBCSG-18-98-BS', 'type': 'OTHER', 'domain': 'IBCSG'}, {'id': 'EU-20623', 'type': 'OTHER', 'domain': 'EU'}, {'id': 'IBCSG-1-98-BS', 'type': 'OTHER', 'domain': 'IBCSG'}, {'id': 'NOVARTIS-2026703019', 'type': 'OTHER', 'domain': 'Novartis'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tamoxifen for 5 years', 'description': 'Patients treated with tamoxifen for 5 years after randomisation.', 'interventionNames': ['Other: laboratory biomarker analysis', 'Procedure: Dual energy X-ray absorptiometry (DEXA)', 'Procedure: Spine X-ray']}, {'type': 'EXPERIMENTAL', 'label': 'Letrozole for 5 years', 'description': 'Patients treated with letrozole for 5 years after randomisation.', 'interventionNames': ['Other: laboratory biomarker analysis', 'Procedure: Dual energy X-ray absorptiometry (DEXA)', 'Procedure: Spine X-ray']}, {'type': 'EXPERIMENTAL', 'label': 'Tamoxifen 2 years plus letrozole 3 years', 'description': 'Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.', 'interventionNames': ['Other: laboratory biomarker analysis', 'Procedure: Dual energy X-ray absorptiometry (DEXA)', 'Procedure: Spine X-ray']}, {'type': 'EXPERIMENTAL', 'label': 'Letrozole 2 years plus tamoxifen 3 years', 'description': 'Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.', 'interventionNames': ['Other: laboratory biomarker analysis', 'Procedure: Dual energy X-ray absorptiometry (DEXA)', 'Procedure: Spine X-ray']}], 'interventions': [{'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.', 'armGroupLabels': ['Letrozole 2 years plus tamoxifen 3 years', 'Letrozole for 5 years', 'Tamoxifen 2 years plus letrozole 3 years', 'Tamoxifen for 5 years']}, {'name': 'Dual energy X-ray absorptiometry (DEXA)', 'type': 'PROCEDURE', 'description': 'Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.', 'armGroupLabels': ['Letrozole 2 years plus tamoxifen 3 years', 'Letrozole for 5 years', 'Tamoxifen 2 years plus letrozole 3 years', 'Tamoxifen for 5 years']}, {'name': 'Spine X-ray', 'type': 'PROCEDURE', 'description': 'Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.', 'armGroupLabels': ['Letrozole 2 years plus tamoxifen 3 years', 'Letrozole for 5 years', 'Tamoxifen 2 years plus letrozole 3 years', 'Tamoxifen for 5 years']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Institute of Oncology at Prince of Wales Hospital', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '4029', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': "Royal Brisbane and Women's Hospital", 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33081', 'city': 'Aviano', 'country': 'Italy', 'facility': 'Centro di Riferimento Oncologico - Aviano', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}, {'zip': '24100', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Ospedali Riuniti di Bergamo', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '20141', 'city': 'Milan', 'country': 'Italy', 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Dunedin', 'country': 'New Zealand', 'facility': 'Dunedin Hospital', 'geoPoint': {'lat': -45.87416, 'lon': 170.50361}}, {'zip': '34', 'city': 'Lima', 'country': 'Peru', 'facility': 'Instituto Nacional de Enfermedades Neoplasicas', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '7925', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Groote Schuur Hospital', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ruber Internacional', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'CH-5001', 'city': 'Aarau', 'country': 'Switzerland', 'facility': 'Kantonspital Aarau', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'zip': 'CH-3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': 'CH-1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': 'CH-6850', 'city': 'Mendrisio', 'country': 'Switzerland', 'facility': 'Ospedale Beata Vergine', 'geoPoint': {'lat': 45.87019, 'lon': 8.9816}}, {'zip': 'CH-9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Kantonsspital - St. Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': '3600', 'city': 'Thun', 'country': 'Switzerland', 'facility': 'Regionalspital', 'geoPoint': {'lat': 46.75118, 'lon': 7.62166}}], 'overallOfficials': [{'name': 'Stefan Aebi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Insel Gruppe AG, University Hospital Bern'}, {'name': 'Andrea Decensi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'European Institute of Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ETOP IBCSG Partners Foundation', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}