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Phase III Companion Study of Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Treated on Protocol CAN-NCIC-MA27
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Related Information Registry Information
Alternate Title
Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial CAN-NCIC-MA27
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase III
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Natural history/Epidemiology, Supportive care
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Closed
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45 and over
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NCI
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CAN-NCIC-MA27B NCIC-MA.27B, SWOG-NCIC-MA27B, NCCTG-NCIC-MA27B, CAN-NCIC-BONE, NCT00354302, MA27B
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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.
Entry 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
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])
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)
Expected Enrollment 408A total of 408 patients will be accrued for this study. Outcomes Primary Outcome(s)Percentage change of bone mineral density (BMD) measured at 2 years (from baseline) in the L1-L4 region of the spine and the hip
Secondary Outcome(s)Percentage change in BMD at 5 years (from baseline) Mean percentage change in BMD at 1, 3, and 5 years (from baseline) 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 at 36 months 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 Pattern of change in bone biomarkers from baseline Clinical safety and tolerability of study medications
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 (e.g., risedronate or alendronate).
Trial Contact Information
Trial Lead Organizations NCIC-Clinical Trials Group | | | Paul Goss, MD, PhD, Protocol chair | | Ph: 617-724-3118; 877-726-5130 |
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North Central Cancer Treatment Group | | | James Ingle, MD, Protocol chair | | | |
Southwest Oncology Group | | | Dawn Hershman, MD, Protocol chair | | | |
Related Information PDQ® clinical trial CAN-NCIC-MA27 (COMPANION)
Registry Information | | Official Title | | The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density In Postmenopausal Women with Primary Breast Cancer | | Trial Start Date | | 2006-04-26 | | Trial Completion Date | | 2010-07-01 (estimated) | | Registered in ClinicalTrials.gov | | NCT00354302 | | Date Submitted to PDQ | | 2006-04-28 | | Information Last Verified | | 2008-05-28 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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