Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial CAN-NCIC-MA27 - Full Text View

Sponsors and Collaborators:	National Cancer Institute of Canada National Cancer Institute (NCI) North Central Cancer Treatment Group Southwest Oncology Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00354302

Purpose

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	Intervention	Phase
Breast Cancer Cancer-Related Problem/Condition	Drug: alendronate sodium Drug: calcium carbonate Drug: calcium citrate Drug: calcium gluconate Drug: cholecalciferol Drug: risedronate sodium Procedure: dual x-ray absorptometry Procedure: laboratory biomarker analysis	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Calcium Cancer Fractures Minerals Osteoporosis

Drug Information available for: Alendronate Alendronate sodium Anastrozole Calcium gluconate Citric acid Sodium Citrate Calcium carbonate Cholecalciferol Risedronate sodium Risedronic acid Calcium citrate Exemestane X-Rays D-Gluconic acid, monosodium salt Gluconic acid Manganese gluconate

U.S. FDA Resources

Study Type:	Observational
Official Title:	The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage change in BMD at 5 years (from baseline) [ Designated as safety issue: No ]
Mean percentage change in BMD at 1, 3, and 5 years (from baseline) [ Designated as safety issue: No ]
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 ... [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
Pattern of change in bone biomarkers from baseline [ Designated as safety issue: No ]
Clinical safety and tolerability of study medications [ Designated as safety issue: Yes ]

Estimated Enrollment:	408
Study Start Date:	April 2006
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

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 (e.g., risedronate or alendronate).

PROJECTED ACCRUAL: A total of 408 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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])

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354302

Show 222 Study Locations

Sponsors and Collaborators

National Cancer Institute of Canada

National Cancer Institute (NCI)

North Central Cancer Treatment Group

Southwest Oncology Group

Investigators

Study Chair:	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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000483099, CAN-NCIC-MA27B, SWOG-NCIC-MA27B, NCCTG-NCIC-MA27B, CAN-NCIC-BONE
Study First Received:	July 19, 2006
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00354302
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Calcium, Dietary
Cholecalciferol
Anastrozole
Skin Diseases
Alendronate
Citric Acid

Osteoporosis
Breast Neoplasms
Calcium Carbonate
Exemestane
Risedronic acid
Breast Diseases

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Calcium Channel Blockers
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions

Membrane Transport Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Antacids
Micronutrients

ClinicalTrials.gov processed this record on January 16, 2009