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

Phase 3

Completed

• Conditions: Breast Cancer; Osteoporosis

• 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.

Study Timeline

• Study Start: 2006-04-24
• Study First Submitted: 2006-07-19
• Study First Submitted QC: 2006-07-19
• Study First Posted: 2006-07-20
• Primary Completion: 2011-03
• Status Verified: 2012-01
• Study Completion: 2012-01-06
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 497

Inclusion Criteria

Not provided

Exclusion Criteria

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)

BCCA - Vancouver Cancer Centre; 🇨🇦 Vancouver, British Columbia, Canada

CancerCare Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

The Moncton Hospital; 🇨🇦 Moncton, New Brunswick, Canada

Atlantic Health Sciences Corporation; 🇨🇦 Saint John, New Brunswick, Canada

Cambridge Memorial Hospital; 🇨🇦 Cambridge, Ontario, Canada

Algoma District Cancer Program; 🇨🇦 Sault Ste. Marie, Ontario, Canada

Thunder Bay Regional Health Science Centre; 🇨🇦 Thunder Bay, Ontario, Canada

Odette Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Univ. Health Network-Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

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