Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial
NCT ID: NCT00354302
Last Updated: 2020-04-02
Study Results
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Basic Information
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COMPLETED
PHASE3
497 participants
INTERVENTIONAL
2006-04-24
2012-01-06
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
QUADRUPLE
Interventions
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calcium carbonate
calcium citrate
cholecalciferol
alendronate sodium
calcium gluconate
risedronate sodium
laboratory biomarker analysis
dual x-ray absorptometry
Eligibility Criteria
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Inclusion Criteria
* 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 \[stratum I\])
45 Years
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
North Central Cancer Treatment Group
NETWORK
SWOG Cancer Research Network
NETWORK
NCIC Clinical Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Paul E. Goss, MD, PhD
Role: STUDY_CHAIR
Massachusetts General Hospital
James N. Ingle, MD
Role: STUDY_CHAIR
Mayo Clinic
Dawn Hershman, MD
Role: STUDY_CHAIR
Herbert Irving Comprehensive Cancer Center
Locations
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BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
The Moncton Hospital
Moncton, New Brunswick, Canada
Atlantic Health Sciences Corporation
Saint John, New Brunswick, Canada
Cambridge Memorial Hospital
Cambridge, Ontario, Canada
Algoma District Cancer Program
Sault Ste. Marie, Ontario, Canada
Thunder Bay Regional Health Science Centre
Thunder Bay, Ontario, Canada
Odette Cancer Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
Hopital Charles LeMoyne
Greenfield Park, Quebec, Canada
CHA-Hopital Du St-Sacrement
Québec, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Countries
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References
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Goss PE, Hershman DL, Cheung AM, Ingle JN, Khosla S, Stearns V, Chalchal H, Rowland K, Muss HB, Linden HM, Scher J, Pritchard KI, Elliott CR, Badovinac-Crnjevic T, St Louis J, Chapman JA, Shepherd LE. Effects of adjuvant exemestane versus anastrozole on bone mineral density for women with early breast cancer (MA.27B): a companion analysis of a randomised controlled trial. Lancet Oncol. 2014 Apr;15(4):474-82. doi: 10.1016/S1470-2045(14)70035-X. Epub 2014 Mar 11.
Other Identifiers
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CAN-NCIC-MA27B
Identifier Type: REGISTRY
Identifier Source: secondary_id
SWOG-NCIC-MA27B
Identifier Type: OTHER
Identifier Source: secondary_id
NCCTG-NCIC-MA27B
Identifier Type: OTHER
Identifier Source: secondary_id
CAN-NCIC-BONE
Identifier Type: -
Identifier Source: secondary_id
CDR0000483099
Identifier Type: OTHER
Identifier Source: secondary_id
MA27B
Identifier Type: -
Identifier Source: org_study_id
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