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

Phase Type Status Age Sponsor Protocol IDs Phase III Natural history/Epidemiology, Supportive care Closed 45 and over NCI CAN-NCIC-MA27B NCIC-MA.27B, SWOG-NCIC-MA27B, NCCTG-NCIC-MA27B, CAN-NCIC-BONE, NCT00354302, MA27B

Objectives

1. 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

A total of 408 patients will be accrued for this study.

Outcomes

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

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

North Central Cancer Treatment Group

James Ingle, MD, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

Southwest Oncology Group

Dawn Hershman, MD, Protocol chair		Ph: 212-305-1945

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