Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IBCSG-18-98-BS | Other Identifier | IBCSG | |
| EU-20623 | Other Identifier | EU | |
| IBCSG-1-98-BS | Other Identifier | IBCSG | |
| NOVARTIS-2026703019 | Other Identifier | Novartis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
OBJECTIVES:
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamoxifen for 5 years | Experimental | Patients treated with tamoxifen for 5 years after randomisation. |
|
| Letrozole for 5 years | Experimental | Patients treated with letrozole for 5 years after randomisation. |
|
| Tamoxifen 2 years plus letrozole 3 years | Experimental | Patients treated with tamoxifen for 2 years and afterwards with letrozole for 3 years. |
|
| Letrozole 2 years plus tamoxifen 3 years | Experimental | Patients treated with letrozole for 2 years and afterwards with tamoxifen for 3 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laboratory biomarker analysis | Other | Biomarkers (C-telopeptide, osteocalcin and skeletal alkaline phosphatase) will be assessed in serum. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 years after randomisation to BIG 1-98 | |
| Recovery of BMD at 1 year after the completion of treatment on protocol IBCSG-1-98 | 6 years after randomisation to BIG 1-98 | |
| Proportion of patients with BMD below the absolute threshold value for osteoporosis | 5 years after randomisation to BIG 1-98 | |
| 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 | 5 years after randomisation to BIG 1-98 | |
| Recovery of the markers of bone resorption at 1 year after the completion of treatment on protocol IBCSG-1-98 | 6 years after randomisation to BIG 1-98 |
Not provided
Not provided
DISEASE CHARACTERISTICS:
Diagnosis of breast cancer
Enrolled on protocol IBCSG-1-98
Receiving adjuvant endocrine therapy comprising 1 of the following regimens:
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:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stefan Aebi, MD | Insel Gruppe AG, University Hospital Bern | Study Chair |
| Andrea Decensi, MD | European Institute of Oncology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Oncology at Prince of Wales Hospital | Randwick | New South Wales | 2031 | Australia | ||
| Royal Brisbane and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24487691 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dual energy X-ray absorptiometry (DEXA) | Procedure | Mone mineral density measurements of L2-L4 and hip will be performed using DEXA. |
|
| Spine X-ray | Procedure | Thoracic and lumbar X-ray (T4-L4, lateral projection) will be performed. |
|
| Brisbane |
| Queensland |
| 4029 |
| Australia |
| Institut Bergonie | Bordeaux | 33076 | France |
| Centro di Riferimento Oncologico - Aviano | Aviano | 33081 | Italy |
| Ospedali Riuniti di Bergamo | Bergamo | 24100 | Italy |
| European Institute of Oncology | Milan | 20141 | Italy |
| Dunedin Hospital | Dunedin | New Zealand |
| Instituto Nacional de Enfermedades Neoplasicas | Lima | 34 | Peru |
| Groote Schuur Hospital | Cape Town | 7925 | South Africa |
| Hospital Ruber Internacional | Madrid | 28034 | Spain |
| Kantonspital Aarau | Aarau | CH-5001 | Switzerland |
| Inselspital Bern | Bern | CH-3010 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | CH-1011 | Switzerland |
| Ospedale Beata Vergine | Mendrisio | CH-6850 | Switzerland |
| Kantonsspital - St. Gallen | Sankt Gallen | CH-9007 | Switzerland |
| Regionalspital | Thun | 3600 | Switzerland |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015502 | Absorptiometry, Photon |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003720 | Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
Not provided
Not provided