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Sponsors and Collaborators: |
NCIC Clinical Trials Group National Cancer Institute (NCI) North Central Cancer Treatment Group Southwest Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00354302 |
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.
Condition | Intervention | Phase |
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Breast Cancer Osteoporosis |
Dietary Supplement: calcium carbonate Dietary Supplement: calcium citrate Dietary Supplement: cholecalciferol Drug: alendronate sodium Drug: calcium gluconate Drug: risedronate sodium Other: laboratory biomarker analysis Procedure: dual x-ray absorptometry |
Phase III |
Study Type: | Observational |
Official Title: | The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer |
Estimated Enrollment: | 408 |
Study Start Date: | April 2006 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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).
PROJECTED ACCRUAL: A total of 408 patients will be accrued for this study.
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Paul E. Goss, MD, PhD | Massachusetts General Hospital |
Study Chair: | James N. Ingle, MD | Mayo Clinic |
Study Chair: | Dawn Hershman, MD | Herbert Irving Comprehensive Cancer Center |
Study ID Numbers: | CDR0000483099, CAN-NCIC-MA27B, SWOG-NCIC-MA27B, NCCTG-NCIC-MA27B, CAN-NCIC-BONE |
Study First Received: | July 19, 2006 |
Last Updated: | May 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00354302 History of Changes |
Health Authority: | United States: Federal Government |
osteoporosis stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Anastrozole Calcium Channel Blockers Bone Density Conservation Agents Calcium Carbonate Bone Diseases Musculoskeletal Diseases Alendronate Vitamins Exemestane Micronutrients Risedronic acid Breast Diseases Cholecalciferol |
Skin Diseases Citric Acid Adjuvants, Immunologic Osteoporosis Breast Neoplasms Bone Diseases, Metabolic Trace Elements Cardiovascular Agents Calcium, Dietary Vitamin D3 Citrate Antacids Calciferol |
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Calcium Channel Blockers Bone Density Conservation Agents Calcium Carbonate Bone Diseases Membrane Transport Modulators Neoplasms by Site Musculoskeletal Diseases Alendronate Vitamins Therapeutic Uses Micronutrients |
Risedronic acid Breast Diseases Cholecalciferol Skin Diseases Growth Substances Osteoporosis Breast Neoplasms Bone Diseases, Metabolic Cardiovascular Agents Pharmacologic Actions Neoplasms Antacids |