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

Breast Cancer 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00354302
• Other study ID #: MA27B
• Secondary ID: CAN-NCIC-MA27BSW
• Status: Completed
• Phase: Phase 3
• Start date: April 24, 2006
• Est. completion date: January 6, 2012

Study information

• Verified date: January 2012
• Source: Canadian Cancer Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 497
• Est. completion date: January 6, 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 120 Years

Eligibility

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])

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Osteoporosis

Intervention

Dietary Supplement:
• calcium carbonate

• calcium citrate

• cholecalciferol

Drug:
• alendronate sodium

• calcium gluconate

• risedronate sodium

Other:
• laboratory biomarker analysis

Procedure:
• dual x-ray absorptometry

Locations

Country	Name	City	State
Canada	Cambridge Memorial Hospital	Cambridge	Ontario
Canada	Hopital Charles LeMoyne	Greenfield Park	Quebec
Canada	The Moncton Hospital	Moncton	New Brunswick
Canada	CHA-Hopital Du St-Sacrement	Quebec City	Quebec
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Atlantic Health Sciences Corporation	Saint John	New Brunswick
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	BCCA - Vancouver Cancer Centre	Vancouver	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba

Sponsors (4)

Lead Sponsor	Collaborator
NCIC Clinical Trials Group	National Cancer Institute (NCI), North Central Cancer Treatment Group, Southwest Oncology Group

Country where clinical trial is conducted

Canada, 

References & 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 b — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage change in BMD at 5 years (from baseline)		5 years
Secondary	Mean percentage change in BMD at 1, 3, and 5 years (from baseline)		5 years
Secondary	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
Secondary	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
Secondary	Pattern of change in bone biomarkers from baseline		5 years
Secondary	Clinical safety and tolerability of study medications		5 years