Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial

Overview

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.

Full Title of Study: “The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2011

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 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

Clinical Trial Outcome Measures

Primary Measures

  • Percentage change of bone mineral density (BMD) measured at 2 years (from baseline) in the L1-L4 region of the spine and the hip
    • Time Frame: 5 years

Secondary Measures

  • Percentage change in BMD at 5 years (from baseline)
    • Time Frame: 5 years
  • Mean percentage change in BMD at 1, 3, and 5 years (from baseline)
    • Time Frame: 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 …
    • Time Frame: 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
    • Time Frame: 5 years
  • Pattern of change in bone biomarkers from baseline
    • Time Frame: 5 years
  • Clinical safety and tolerability of study medications
    • Time Frame: 5 years

Participating in This Clinical Trial

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])

Gender Eligibility: Female

Minimum Age: 45 Years

Maximum Age: 120 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NCIC Clinical Trials Group
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Paul E. Goss, MD, PhD, Study Chair, Massachusetts General Hospital
    • James N. Ingle, MD, Study Chair, Mayo Clinic
    • Dawn Hershman, MD, Study Chair, Herbert Irving Comprehensive Cancer Center

Citations Reporting on Results

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.

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