Phase III Trial of Intravenous Zoledronic Acid (Zometa) in the Prevention of Bone Loss in Localized Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure
Phase III Trial of Intravenous Zoledronic Acid (Zometa) in the Prevention of Bone Loss in Localized Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure
RATIONALE: Zoledronate plus calcium and vitamin D may prevent bone loss in patients receiving adjuvant chemotherapy for breast cancer. It is not yet known which regimen is more effective in preventing bone loss.
PURPOSE: This randomized phase III trial is comparing two regimens of zoledronate plus calcium and vitamin D to see how well they work in preventing bone loss in women who are receiving adjuvant chemotherapy for breast cancer.
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to intent to treat with tamoxifen (yes vs no) and node status (negative vs positive vs unknown [for patients receiving neoadjuvant therapy]). Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: Approximately 400 patients (200 per treatment arm) will be accrued for this study within 24 months.
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast by fine needle aspirate, biopsy (tru-cut, core, stereotactic), lumpectomy, or modified radical mastectomy
Plan to use adjuvant chemotherapy* with or without adjuvant endocrine therapy*
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
See Disease Characteristics
Premenopausal, defined as actively menstruating or last menstrual period occurred within 6 months prior to study entry
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Washington D.C., District of Columbia 20007, United States
Washington D.C., District of Columbia 20010, United States
Fort Lauderdale, Florida 33308, United States
La Porte, Indiana 46350, United States
Scarborough, Maine 04074, United States
Baltimore, Maryland 21201, United States
Baltimore, Maryland 21237, United States
Elkton MD, Maryland 21921, United States
Boston, Massachusetts 02115, United States
Voorhees Township, New Jersey 08043, United States
Staten Island, New York 10305, United States
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Columbus, Ohio 43210-1240, United States
Pittsburgh, Pennsylvania 15224-1791, United States
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