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

Sponsor

NCIC Clinical Trials Group (Other)

Overall Status

Completed

CT.gov ID

NCT00354302

Collaborator

National Cancer Institute (NCI) (NIH), North Central Cancer Treatment Group (Other), Southwest Oncology Group (Other)

497

Enrollment

Locations

68.4

Actual Duration (Months)

38.2

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Osteoporosis	Dietary Supplement: calcium carbonate Dietary Supplement: calcium citrate Dietary Supplement: cholecalciferol Drug: alendronate sodium Drug: calcium gluconate Drug: risedronate sodium Other: laboratory biomarker analysis Procedure: dual x-ray absorptometry	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

497 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer

Actual Study Start Date :

Apr 24, 2006

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Jan 6, 2012

Outcome Measures

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 [5 years]

Secondary Outcome Measures

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]
Clinical safety and tolerability of study medications [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 120 Years

Sexes Eligible for Study:

Female

Accepts 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])

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BCCA - Vancouver Cancer Centre	Vancouver	British Columbia	Canada	V5Z 4E6
2	CancerCare Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
3	The Moncton Hospital	Moncton	New Brunswick	Canada	E1C 6Z8
4	Atlantic Health Sciences Corporation	Saint John	New Brunswick	Canada	E2L 4L2
5	Cambridge Memorial Hospital	Cambridge	Ontario	Canada	N1R 3G2
6	Algoma District Cancer Program	Sault Ste. Marie	Ontario	Canada	P6B 0A8
7	Thunder Bay Regional Health Science Centre	Thunder Bay	Ontario	Canada	P7B 6V4
8	Odette Cancer Centre	Toronto	Ontario	Canada	M4N 3M5
9	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8
10	Univ. Health Network-Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
11	Hopital Charles LeMoyne	Greenfield Park	Quebec	Canada	J4V 2H1
12	CHA-Hopital Du St-Sacrement	Quebec City	Quebec	Canada	G1S 4L8
13	Allan Blair Cancer Centre	Regina	Saskatchewan	Canada	S4T 7T1