Breast Cancer, Osteoporosis
Conditions
Keywords
osteoporosis, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
Brief summary
RATIONALE: Learning about the effect of exemestane and anastrozole on bone mineral density in postmenopausal women with primary breast cancer may help plan treatment, decrease the risk of broken bones, and help patients live more comfortably. PURPOSE: This phase III trial is studying bone mineral density in postmenopausal women with primary breast cancer who are receiving treatment on clinical trial CAN-NCIC-MA27.
Detailed description
OBJECTIVES: * Determine whether there is a clinically relevant difference in bone mineral density (BMD) at 2 years in postmenopausal women with primary breast cancer (with or without osteopenia or osteoporosis) treated with exemestane vs anastrozole on protocol CAN-NCIC-MA27. OUTLINE: This is a multicenter, companion study. Patients are stratified according to baseline bone mineral density (BMD) measurement (T-score\* ≥ -2.0 standard deviation \[SD\] \[no osteopenia or osteoporosis\] vs T-score\* \< -2.0 SD). NOTE: \*The lowest of the two T-scores: L1-L4 or total hip Blood samples for the identification of bone biomarkers (formation marker: serum amino-terminal procollagen 1 extension peptide \[P1NP\] and resorption marker: serum N-telopeptide) are obtained at baseline and at 6 and 12 months. BMD is determined by dual-energy x-ray absorptiometry (DEXA) at baseline and then annually for 5 years (or for as long as patient is receiving treatment on protocol CAN-NCIC-MA27). Patients receive oral calcium and oral cholecalciferol (vitamin D) daily. Patients with osteopenia or osteoporosis (stratum II) also receive oral bisphosphonate therapy PROJECTED ACCRUAL: A total of 408 patients will be accrued for this study.
Interventions
DIETARY_SUPPLEMENTcalcium carbonate
DIETARY_SUPPLEMENTcalcium citrate
DIETARY_SUPPLEMENTcholecalciferol
OTHERlaboratory biomarker analysis
PROCEDUREdual x-ray absorptometry
Sponsors
National Cancer Institute (NCI)
North Central Cancer Treatment Group
SWOG Cancer Research Network
NCIC Clinical Trials Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Enrolled in and meets eligibility requirements for protocol CAN-NCIC-MA27 * Acceptable quality dual-energy x-ray absorptiometry (DEXA) of the L1-L4 postero-anterior spine and hip within 12 weeks prior to randomization on protocol CAN-NCIC-MA27 * Hormone receptor status: * Estrogen receptor- and/or progesterone receptor-positive tumor PATIENT CHARACTERISTICS: * Female * Postmenopausal * No malabsorption syndrome * No known cholecalciferol (vitamin D) deficiency, active hyper- or hypoparathyroidism, or Paget's disease * No uncontrolled thyroid disease, Cushing's disease, or other pituitary disease * No other bone disease (including osteomalacia or osteogenesis imperfecta) PRIOR CONCURRENT THERAPY: * More than 6 months since prior drugs (investigational or not), including bisphosphonates, for the prevention of osteoporosis (stratum I) * More than 12 months since prior and no concurrent anticonvulsants * More than 6 months since prior and no concurrent corticosteroids at doses \> 5 mg/day of prednisone (or equivalent) for \> 2 weeks * More than 12 months since prior and no concurrent anabolic steroids * No prior bisphosphonates (stratum II) * No concurrent sodium fluoride at daily doses ≥ 5 mg/day * No long-term (i.e., \> 6 months) use of coumarins * No concurrent drugs (investigational or not), including bisphosphonates, for the prevention of osteoporosis (for patients with no osteopenia or osteoporosis \[stratum I\])
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change of bone mineral density (BMD) measured at 2 years (from baseline) in the L1-L4 region of the spine and the hip | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Mean percentage change in BMD at 1, 3, and 5 years (from baseline) | 5 years |
| Proportion of patients without osteopenia or osteoporosis (stratum I) who develop BMD below the absolute threshold for osteopenia (< -2.0 standard deviation below the mean), suffer any osteoporotic fracture, or have an asymptomatic fracture revealed ... | 5 years |
| Percentage change in BMD at 5 years (from baseline) | 5 years |
| Pattern of change in bone biomarkers from baseline | 5 years |
| Clinical safety and tolerability of study medications | 5 years |
| Percentage of patients with osteopenia or osteoporosis (stratum II) who have ≥ 5% improvement of BMD at 2 years post randomization on protocol CAN-NCIC-MA27 and who have clinically apparent osteoporosis-related fracture of the long bones | 5 years |
Countries
Canada
Outcome results
None listed