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

NCT00354302 | Completed Phase 3 DMC

• 6 other identifiers: MA27BCAN-NCIC-MA27BSWOG-NCIC-MA27BNCCTG-NCIC-MA27BCAN-NCIC-BONECDR0000483099
• Study Type: interventional
• Target: 497
• Locations: 1 country
• Sites: 13

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.

Conditions

Breast Cancer; Osteoporosis

Keywords

osteoporosis; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

• Pattern of change in bone biomarkers from baseline

  5 years

Interventions

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

Eligibility Criteria

• Age: 45 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 \[stratum I\])

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• National Cancer Institute (NCI): collaborator
• North Central Cancer Treatment Group: collaborator
• SWOG Cancer Research Network: collaborator

Study Sites (13)

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

The Moncton Hospital

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Atlantic Health Sciences Corporation

Saint John, New Brunswick, E2L 4L2, Canada

Location

Cambridge Memorial Hospital

Cambridge, Ontario, N1R 3G2, Canada

Location

Algoma District Cancer Program

Sault Ste. Marie, Ontario, P6B 0A8, Canada

Location

Thunder Bay Regional Health Science Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Charles LeMoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

CHA-Hopital Du St-Sacrement

Québec, Quebec, G1S 4L8, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (1)

• 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.

  PMID: 24636210 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Osteoporosis

Interventions

Calcium Carbonate; Calcium Citrate; Cholecalciferol; Alendronate; Calcium Gluconate; Risedronic Acid; Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals; Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Diphosphonates; Organophosphonates; Organophosphorus Compounds; Gluconates; Sugar Acids; Hydroxy Acids; Carbohydrates; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Paul E. Goss, MD, PhD

  Massachusetts General Hospital

  STUDY CHAIR

• James N. Ingle, MD

  Mayo Clinic

  STUDY CHAIR

• Dawn Hershman, MD

  Herbert Irving Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2006
• First Posted: July 20, 2006
• Study Start: April 24, 2006
• Primary Completion: March 1, 2011
• Study Completion: January 6, 2012
• Last Updated: April 2, 2020

Record last verified: 2012-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (13)