Breast Cancer, Osteoporosis
Conditions
Keywords
osteoporosis, estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
Brief 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).
Detailed description
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
OTHERlaboratory biomarker analysis
Serial serum levels of several biomarkers will be analyzed at different time points, up to 72 months after randomization.
PROCEDUREdual x-ray absorptiometry
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).
Sponsors
National Cancer Institute (NCI)
Breast International Group
ETOP IBCSG Partners Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | 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 |
Countries
Australia, Belgium, Switzerland
Outcome results
None listed