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| ID | Type | Description | Link |
|---|---|---|---|
| IBCSG-25A-02 | |||
| BIG-25A-02 | |||
| NABCI-IBCSG-25A-02 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Breast International Group | OTHER |
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RATIONALE: Gathering information over time from bone density and laboratory tests of women with breast cancer treated with triptorelin and tamoxifen or exemestane may help the study of breast cancer in the future.
PURPOSE: This clinical trial is studying changes in bone mineral density in women with breast cancer treated with triptorelin and tamoxifen or exemestane on protocol IBC SG-25-02 (TEXT).
OBJECTIVES:
OUTLINE: Blood samples are collected at baseline and then periodically for 6 years. Serum markers of bone remodeling and serum growth factor levels are measured.
Bone mineral density in the L1-L4 (postero-anterior) region of the spine and femoral neck of the hip is measured by DEXA at baseline and then periodically for 6 years.
Any surplus serum is stored for use in unspecified future research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triptorelin plus tamoxifen | Active Comparator | Determination of bone mineral density in patients randomized in TEXT-1 or TEXT-2 trials to receive triptorelin (GnRH analogue) for 5 years plus tamoxifen for 5 years. |
|
| Triptorelin plus exemestane | Experimental | Determination of bone mineral density in patients randomized in TEXT-1 or TEXT-2 trials to receive triptorelin (GnRH analogue) for 5 years plus exemestane for 5 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laboratory biomarker analysis | Other | Serial serum levels of several biomarkers will be analyzed at different time points, up to 72 months after randomization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase | 72 months after rnadomization to TEXT Study | |
| Serial serum levels of IGF-1 and IGFBP-3 | 72 months after randomization to TEXT Study | |
| Serial BMD measurements of the L1-L4 (postero-anterior, PA) region of the spine and hip by dual-energy X-ray absorptiometry (DEXA) | 72 months after randomization to TEXT Study |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Olivia Pagani, MD | Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brisbane and Women's Hospital | Brisbane | Australia | ||||
| Peter MacCallum Cancer Center |
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| dual x-ray absorptiometry | Procedure | Serial bone mineral density measurements of the L1-L4 (postero-anterior, PA) region of the spine and hip by dual-energy X-ray absorptiometry (DEXA). |
|
| East Melbourne |
| Australia |
| Box Hill Hospital | Melbourne | Australia |
| Maroondah Hospital | Melbourne | Australia |
| Royal Perth Hospital | Perth | Australia |
| Centre Hospitalier Regional de Huy | Huy | Belgium |
| UZ Leuven | Leuven | Belgium |
| C.H.U. Sart Tilman | Liège | Belgium |
| CHR Citadelle | Liège | Belgium |
| C.H.P.L.T. de Verviers | Verviers | Belgium |
| Oncology Institute of Southern Switzerland | Bellinzona | CH-6500 | Switzerland |
| Inselspital Bern | Bern | Switzerland |
| Kantonsspital St.Gallen | Sankt Gallen | 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 |
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| 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 |
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