The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer
45 Years
N/A
Female
Breast Cancer, Osteoporosis
Trial Information
The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer
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.
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])
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Outcome Measure:
Percentage change of bone mineral density (BMD) measured at 2 years (from baseline) in the L1-L4 region of the spine and the hip
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Paul E. Goss, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Massachusetts General Hospital
Authority:
Canada: Health Canada
Study ID:
MA27B
NCT ID:
NCT00354302
Start Date:
April 2006
Completion Date:
March 2011
Related Keywords:
- Breast Cancer
- Osteoporosis
- osteoporosis
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- Breast Neoplasms
- Osteoporosis
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