Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial
- Conditions
- Breast CancerOsteoporosis
- Registration Number
- NCT00354302
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 497
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Percentage change of bone mineral density (BMD) measured at 2 years (from baseline) in the L1-L4 region of the spine and the hip 5 years
- Secondary Outcome Measures
Name Time Method Clinical safety and tolerability of study medications 5 years Percentage change in BMD at 5 years (from baseline) 5 years Mean percentage change in BMD at 1, 3, and 5 years (from baseline) 5 years Pattern of change in bone biomarkers from baseline 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 ... 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 5 years
Trial Locations
- Locations (13)
Cambridge Memorial Hospital
🇨🇦Cambridge, 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
🇨🇦Quebec City, Quebec, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Algoma District Cancer Program
🇨🇦Sault Ste. Marie, Ontario, Canada
Thunder Bay Regional Health Science Centre
🇨🇦Thunder Bay, Ontario, Canada
The Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
Atlantic Health Sciences Corporation
🇨🇦Saint John, New Brunswick, Canada