Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial CAN-NCIC-MA27
Information source: NCIC Clinical Trials Group
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer; Osteoporosis
Intervention: calcium carbonate (Dietary Supplement); calcium citrate (Dietary Supplement); cholecalciferol (Dietary Supplement); alendronate sodium (Drug); calcium gluconate (Drug); risedronate sodium (Drug); laboratory biomarker analysis (Other); dual x-ray absorptometry (Procedure)
Phase: Phase 3
Status: Completed
Sponsored by: NCIC Clinical Trials Group Official(s) and/or principal investigator(s): Paul E. Goss, MD, PhD, Study Chair, Affiliation: Massachusetts General Hospital James N. Ingle, MD, Study Chair, Affiliation: Mayo Clinic Dawn Hershman, MD, Study Chair, Affiliation: Herbert Irving Comprehensive Cancer Center
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.
Clinical Details
Official title: The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer
Study design: Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Primary outcome: Percentage change of bone mineral density (BMD) measured at 2 years (from baseline) in the L1-L4 region of the spine and the hip
Secondary outcome: 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 ... 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
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.
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Female.
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
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 and Contacts
BCCA - Vancouver Cancer Centre, Vancouver, British Columbia V5Z 4E6, Canada
CancerCare Manitoba, Winnipeg, Manitoba R3E 0V9, Canada
The Moncton Hospital, Moncton, New Brunswick E1C 6Z8, Canada
Atlantic Health Sciences Corporation, Saint John, New Brunswick E2L 4L2, Canada
Cambridge Memorial Hospital, Cambridge, Ontario N1R 3G2, Canada
Algoma District Cancer Program, Sault Ste. Marie, Ontario P6B 0A8, Canada
Thunder Bay Regional Health Science Centre, Thunder Bay, Ontario P7B 6V4, Canada
Odette Cancer Centre, Toronto, Ontario M4N 3M5, Canada
St. Michael's Hospital, Toronto, Ontario M5B 1W8, Canada
Univ. Health Network-Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada
Hopital Charles LeMoyne, Greenfield Park, Quebec J4V 2H1, Canada
CHA-Hopital Du St-Sacrement, Quebec City, Quebec G1S 4L8, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan S4T 7T1, Canada
Additional Information
Starting date: April 2006
Last updated: January 9, 2012
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