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

NCIC Clinical Trials Group497 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Enrollment

497

Conditions

Breast Cancer Osteoporosis

Interventions

calcium carbonateDIETARY_SUPPLEMENT

calcium citrateDIETARY_SUPPLEMENT

cholecalciferolDIETARY_SUPPLEMENT

alendronate sodiumDRUG

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 120 Years

Medical Language ↔ Plain English

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 \[stratum I\])

Locations (13)

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

The Moncton Hospital

Moncton, New Brunswick, Canada

Outcomes

Primary 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

Time frame: 5 years

Secondary Outcomes

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

Data from ClinicalTrials.gov

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