OTHER
laboratory biomarker analysis
Serial serum levels of several biomarkers will be analyzed at different time points, up to 72 months after randomization.
Status
Completed
Phase
Not applicable
Enrollment
119
Locations
13
Results
Not posted
Publications
0
Study summary
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: * Evaluate changes in bone mineral density (BMD) among premenopausal women randomized in protocol IBC SG-25202 (TEXT-2) to receive either: A) triptorelin (GnRH analogue) for 5 years plus tamoxifen for 5 years; or B) triptorelin (GnRH analogue) for 5 years plus the steroidal aromatase inhibitor exemestane for 5 years. * Evaluate serial serum markers for bone remodeling (C-telopeptide, osteocalcin, bone-specific alkaline phosphatase) and investigate their correlation with BMD. * Evaluate the relationship of genetic variants of CYP19A1, ERα, ERß, and IGF 1 with BMD. * Evaluate serial serum growth factors (IGF-1 and IGFBP-3) and investigate whether their time course correlates with BMD. * Explore the role of serum IGF-1 and IGFBP-3 as biomarkers of disease outcome (disease-free survival). (exploratory) 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.
Interventions
OTHER
Serial serum levels of several biomarkers will be analyzed at different time points, up to 72 months after randomization.
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).
Timeline
First posted
Aug 21, 2009
Study start
Aug 3, 2009
Primary completion
Mar 11, 2011
Study completion
Oct 23, 2024
Results posted
Not reported
Registry updated
Jul 14, 2025
Outcomes
Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase
Time frame · 72 months after rnadomization to TEXT Study
Serial serum levels of IGF-1 and IGFBP-3
Time frame · 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)
Time frame · 72 months after randomization to TEXT Study
Not reported in the indexed record.
Eligibility
DISEASE CHARACTERISTICS: * Patient must be eligible and enrolled in the TEXT-2 trial prior to enrolling in TEXT-Bone * Serial bone marrow density (BMD) measurements must be taken within the same institution * Hormone receptor positive PATIENT CHARACTERISTICS: * See Disease Characteristics * Premenopausal * No bone fracture in the past 6 months that, in the investigator's judgement, could be related to bone fragility * No clinical or biochemical malabsorption syndrome, known vitamin D deficiency, active hyper- or hypoparathyroidism, or Paget's disease * No uncontrolled thyroid disease, Cushing disease, or other pituitary diseases * No other bone disease (including osteomalacia or osteogenesis imperfecta) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 6 months since prior and no concurrent bisphosphonate therapy (or other bone therapies such as PTH or strontium) * At least 6 months since prior glucocorticoid (\> 5 mg prednisone or equivalent) for \> 1 month * At least 12 months since prior anticonvulsants
Study locations
Australia · Belgium · Switzerland. Showing up to 24 locations stored in the fast local snapshot.
Royal Brisbane and Women's Hospital
Brisbane, Australia
Peter MacCallum Cancer Center
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, Switzerland
Inselspital Bern
Bern, Switzerland
Kantonsspital St.Gallen
Sankt Gallen, Switzerland
Publications
No PMID-linked publications were present in this registry snapshot.
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