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

Primary Purpose

Breast Cancer, Osteoporosis

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
calcium carbonate
calcium citrate
cholecalciferol
alendronate sodium
calcium gluconate
risedronate sodium
laboratory biomarker analysis
dual x-ray absorptometry
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring osteoporosis, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer

Eligibility Criteria

45 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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])

Sites / Locations

  • BCCA - Vancouver Cancer Centre
  • CancerCare Manitoba
  • The Moncton Hospital
  • Atlantic Health Sciences Corporation
  • Cambridge Memorial Hospital
  • Algoma District Cancer Program
  • Thunder Bay Regional Health Science Centre
  • Odette Cancer Centre
  • St. Michael's Hospital
  • Univ. Health Network-Princess Margaret Hospital
  • Hopital Charles LeMoyne
  • CHA-Hopital Du St-Sacrement
  • Allan Blair Cancer Centre

Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

First Posted
July 19, 2006
Last Updated
March 31, 2020
Sponsor
NCIC Clinical Trials Group
Collaborators
National Cancer Institute (NCI), North Central Cancer Treatment Group, SWOG Cancer Research Network
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1. Study Identification

Unique Protocol Identification Number
NCT00354302
Brief Title
Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial
Official Title
The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 24, 2006 (Actual)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
January 6, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group
Collaborators
National Cancer Institute (NCI), North Central Cancer Treatment Group, SWOG Cancer Research Network

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Osteoporosis
Keywords
osteoporosis, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
497 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
calcium carbonate
Intervention Type
Dietary Supplement
Intervention Name(s)
calcium citrate
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol
Intervention Type
Drug
Intervention Name(s)
alendronate sodium
Intervention Type
Drug
Intervention Name(s)
calcium gluconate
Intervention Type
Drug
Intervention Name(s)
risedronate sodium
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Procedure
Intervention Name(s)
dual x-ray absorptometry
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Percentage change in BMD at 5 years (from baseline)
Time Frame
5 years
Title
Mean percentage change in BMD at 1, 3, and 5 years (from baseline)
Time Frame
5 years
Title
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
Title
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
Title
Pattern of change in bone biomarkers from baseline
Time Frame
5 years
Title
Clinical safety and tolerability of study medications
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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])
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul E. Goss, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
James N. Ingle, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dawn Hershman, MD
Organizational Affiliation
Herbert Irving Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
BCCA - Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
The Moncton Hospital
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
Atlantic Health Sciences Corporation
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Cambridge Memorial Hospital
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 3G2
Country
Canada
Facility Name
Algoma District Cancer Program
City
Sault Ste. Marie
State/Province
Ontario
ZIP/Postal Code
P6B 0A8
Country
Canada
Facility Name
Thunder Bay Regional Health Science Centre
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
Facility Name
Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Univ. Health Network-Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hopital Charles LeMoyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
CHA-Hopital Du St-Sacrement
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24636210
Citation
Goss PE, Hershman DL, Cheung AM, Ingle JN, Khosla S, Stearns V, Chalchal H, Rowland K, Muss HB, Linden HM, Scher J, Pritchard KI, Elliott CR, Badovinac-Crnjevic T, St Louis J, Chapman JA, Shepherd LE. Effects of adjuvant exemestane versus anastrozole on bone mineral density for women with early breast cancer (MA.27B): a companion analysis of a randomised controlled trial. Lancet Oncol. 2014 Apr;15(4):474-82. doi: 10.1016/S1470-2045(14)70035-X. Epub 2014 Mar 11.
Results Reference
result

Learn more about this trial

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

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