Bone Density and Bone Loss in Postmenopausal Women With Breast Cancer Receiving Treatment in Clinical Trial IBCSG-1-98
NCT ID: NCT00369850
Last Updated: 2012-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
458 participants
INTERVENTIONAL
2004-05-31
2012-01-31
Brief Summary
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PURPOSE: 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.
Detailed Description
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* 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.
* Compare the incidence of radiological gross changes and fractures identified from spine x-rays (T4-L4) in these patients (in groups 1 and 2).
* Use longitudinal BMD measurements to estimate a linear rate of bone loss based on mixed effect models.
* Identify serum markers for bone loss to determine how they correlate with osteoporosis, microfractures, clinical fractures, and breast cancer-related bone events.
OUTLINE: 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.
* 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.
* 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.
* 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).
Patients undergo blood collection at baseline and periodically during study for biomarker correlative study.
PROJECTED ACCRUAL: A total of 660 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Tamoxifen for 5 years
Patients treated with tamoxifen for 5 years after randomisation.
laboratory biomarker analysis
Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
Dual energy X-ray absorptiometry (DEXA)
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
Spine X-ray
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
Letrozole for 5 years
Patients treated with letrozole for 5 years after randomisation.
laboratory biomarker analysis
Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
Dual energy X-ray absorptiometry (DEXA)
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
Spine X-ray
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
Tamoxifen 2 years plus letrozole 3 years
Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years.
laboratory biomarker analysis
Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
Dual energy X-ray absorptiometry (DEXA)
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
Spine X-ray
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
Letrozole 2 years plus tamoxifen 3 years
Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years.
laboratory biomarker analysis
Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
Dual energy X-ray absorptiometry (DEXA)
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
Spine X-ray
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
Interventions
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laboratory biomarker analysis
Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum.
Dual energy X-ray absorptiometry (DEXA)
Mone mineral density measurements of L2-L4 and hip will be performed using DEXA.
Spine X-ray
Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of breast cancer
* Resected disease
* Enrolled on protocol IBCSG-1-98
* Receiving adjuvant endocrine therapy comprising 1 of the following regimens:
* Letrozole
* Tamoxifen
* Letrozole after 2 years of tamoxifen
* Tamoxifen after 2 years of letrozole
* Not yet completed 5 years of treatment
* No breast cancer recurrence or second primary cancer
* No known, symptomatic bone disease, including osteomalacia or osteogenesis imperfecta
* No prior registration to protocol IBCSG-1-98 Bone Mineral Density substudy
* Hormone receptor status:
* Estrogen receptor-positive and/or progesterone receptor-positive tumor
PATIENT CHARACTERISTICS:
* Female
* Postmenopausal
* No uncontrolled thyroid or parathyroid disease, Cushing's disease, or other pituitary diseases
* No malabsorption syndrome or clinically relevant vitamin D deficiency
* No patients for whom the bone density determination is impossible
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 1 year since prior and no concurrent anticonvulsants
* More than 6 weeks since prior and no concurrent corticosteroids (at doses \> the equivalent of 5 mg/day prednisone) for \> 2 weeks total
* No prior or concurrent sodium fluoride (at daily doses ≥ 5 mg/day) for \> 1 month
* More than 12 months since prior and no concurrent anabolic steroids
* More than 6 months since prior treatment, either investigational or not, for the prevention of osteoporosis (excluding calcium or cholecalciferol \[vitamin D\])
* No concurrent raloxifene
* Concurrent therapeutic intervention for osteoporosis comprising bisphosphonates allowed
* Concurrent warfarin allowed provided it is given for ≤ 4 weeks
30 Years
FEMALE
No
Sponsors
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ETOP IBCSG Partners Foundation
NETWORK
Responsible Party
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Principal Investigators
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Stefan Aebi, MD
Role: STUDY_CHAIR
Insel Gruppe AG, University Hospital Bern
Andrea Decensi, MD
Role: STUDY_CHAIR
European Institute of Oncology
Locations
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Institute of Oncology at Prince of Wales Hospital
Randwick, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Institut Bergonie
Bordeaux, , France
Centro di Riferimento Oncologico - Aviano
Aviano, , Italy
Ospedali Riuniti di Bergamo
Bergamo, , Italy
European Institute of Oncology
Milan, , Italy
Dunedin Hospital
Dunedin, , New Zealand
Instituto Nacional de Enfermedades Neoplasicas
Lima, , Peru
Groote Schuur Hospital
Cape Town, , South Africa
Hospital Ruber Internacional
Madrid, , Spain
Kantonspital Aarau
Aarau, , Switzerland
Inselspital Bern
Bern, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Ospedale Beata Vergine
Mendrisio, , Switzerland
Kantonsspital - St. Gallen
Sankt Gallen, , Switzerland
Regionalspital
Thun, , Switzerland
Countries
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References
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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.
Other Identifiers
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IBCSG-18-98-BS
Identifier Type: OTHER
Identifier Source: secondary_id
EU-20623
Identifier Type: OTHER
Identifier Source: secondary_id
IBCSG-1-98-BS
Identifier Type: OTHER
Identifier Source: secondary_id
NOVARTIS-2026703019
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000482381
Identifier Type: -
Identifier Source: org_study_id