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.
- Compare the bone mineral density in the lumbar spine after 12 and 36 months of therapy
with zoledronate, calcium, and cholecalciferol (vitamin D) in women with breast cancer
receiving adjuvant chemotherapy.
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.
- Arm I: Beginning on the first day of adjuvant chemotherapy (or within 3 months after
the first day), patients receive zoledronate IV over at least 15 minutes once every 3
months during months 1-24 and oral calcium and oral cholecalciferol (vitamin D) daily
during months 1-36.
- Arm II: Beginning on the first day of adjuvant chemotherapy (or within 3 months after
the first day), patients receive oral calcium and oral vitamin D daily during months
1-36 and zoledronate IV over at least 15 minutes once every 3 months during months
13-36.
PROJECTED ACCRUAL: Approximately 400 patients (200 per treatment arm) will be accrued for
this study within 24 months.
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Female.
Arroyo Grande Community Hospital, Arroyo Grande, California 93420, United States
Rebecca and John Moores UCSD Cancer Center, La Jolla, California 92093-0658, United States
El Camino Hospital, Mountain View, California 94040, United States
Naval Medical Center - San Diego, San Diego, California 92134, United States
Veterans Affairs Medical Center - San Diego, San Diego, California 92161, United States
Kent General Hospital at Bayhealth Medical Center, Dover, Delaware 19901, United States
Beebe Medical Center, Lewes, Delaware 19958, United States
CCOP - Christiana Care Health Services, Newark, Delaware 19713, United States
St. Francis Hospital, Wilmington, Delaware 19805, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington, District of Columbia 20007, United States
Sibley Memorial Hospital, Washington, District of Columbia 20016, United States
Washington Cancer Institute at Washington Hospital Center, Washington, District of Columbia 20010, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital, Fort Lauderdale, Florida 33308, United States
Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida 33021, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center, Jupiter, Florida 33458, United States
CCOP - Mount Sinai Medical Center, Miami Beach, Florida 33140, United States
Cancer Research Network, Incorporated, Plantation, Florida 33324, United States
Cleveland Clinic Florida - Weston, Weston, Florida 33331, United States
St. Joseph Medical Center, Bloomington, Illinois 61701, United States
Graham Hospital, Canton, Illinois 61520, United States
Memorial Hospital, Carthage, Illinois 62321, United States
University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States
Eureka Community Hospital, Eureka, Illinois 61530, United States
Galesburg Clinic, Galesburg, Illinois 61401, United States
Galesburg Cottage Hospital, Galesburg, Illinois 61401, United States
InterCommunity Cancer Center of Western Illinois, Galesburg, Illinois 61401, United States
Mason District Hospital, Havana, Illinois 62644, United States
Hopedale Medical Complex, Hopedale, Illinois 61747, United States
Kewanee Hospital, Kewanee, Illinois 61443, United States
La Grange Memorial Hospital, La Grange, Illinois 60525, United States
McDonough District Hospital, Macomb, Illinois 61455, United States
BroMenn Regional Medical Center, Normal, Illinois 61761, United States
Community Cancer Center, Normal, Illinois 61761, United States
Advocate Christ Medical Center, Oak Lawn, Illinois 60453-2699, United States
Community Hospital of Ottawa, Ottawa, Illinois 61350, United States
Cancer Treatment Center at Pekin Hospital, Pekin, Illinois 61554, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois 61615, United States
Methodist Medical Center of Illinois, Peoria, Illinois 61636, United States
Oncology/Hematology Associates of Central Illinois, P.C., Peoria, Illinois 61615, United States
OSF St. Francis Medical Center, Peoria, Illinois 61637, United States
Proctor Hospital, Peoria, Illinois 61614, United States
Illinois Valley Community Hospital, Peru, Illinois 61354, United States
Perry Memorial Hospital, Princeton, Illinois 61356, United States
St. Margaret's Hospital, Spring Valley, Illinois 61362, United States
Valley Cancer Center, Spring Valley, Illinois 61362, United States
Elkhart General Hospital, Elkhart, Indiana 46515, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana 46350, United States
Suniti Medical Corporation, Merrillville, Indiana 46410, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana 46601, United States
Memorial Hospital of South Bend, South Bend, Indiana 46601, United States
Saint Joseph Regional Medical Center, South Bend, Indiana 46617, United States
Hematology Oncology Associates of the Quad Cities, Bettendorf, Iowa 52722, United States
Iowa Blood and Cancer Care, Cedar Rapids, Iowa 52402, United States
Mercy Regional Cancer Center at Mercy Medical Center, Cedar Rapids, Iowa 52403, United States
St. Luke's Hospital, Cedar Rapids, Iowa 52402, United States
Central Maine Medical Center, Lewiston, Maine 04240, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough, Scarborough, Maine 04074, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland 21201, United States
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center, Baltimore, Maryland 21237, United States
Union Hospital Cancer Center at Union Hospital, Elkton MD, Maryland 21921, United States
Sturdy Memorial Hospital, Attleboro, Massachusetts 02703, United States
Brigham and Women's Hospital, Boston, Massachusetts 02115, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States
Faulkner Hospital, Boston, Massachusetts 02130, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, United States
Bethke Cancer Center at Emerson Hospital, Concord, Massachusetts 01742, United States
Lowell General Hospital, Lowell, Massachusetts 01854, United States
Fairview University Medical Center - University Campus, Minneapolis, Minnesota 55455, United States
Saint Luke's Hospital, Chesterfield, Missouri 63017, United States
CCOP - Kansas City, Kansas City, Missouri 64131, United States
Siteman Cancer Center at Barnes-Jewish Hospital, St Louis, Missouri 63110, United States
Missouri Baptist Cancer Center, St. Louis, Missouri 63131, United States
Missouri Cancer Care, P. C. - Wentzville, Wentzville, Missouri 63385, United States
Methodist Cancer Center at Methodist Hospital - Omaha, Omaha, Nebraska 68114, United States
CCOP - Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States
University Medical Center of Southern Nevada, Las Vegas, Nevada 89102, United States
New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett, New Hampshire 03106, United States
Lakes Region General Hospital, Laconia, New Hampshire 03246, United States
Elliot Regional Cancer Center, Manchester, New Hampshire 03103, United States
Oncology Center at St. Joseph Hospital, Nashua, New Hampshire 03060, United States
Jersey City Medical Center at Liberty Health, Jersey City, New Jersey 07302, United States
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees, Voorhees, New Jersey 08043, United States
Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States
Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States
Nalitt Cancer Institute at Staten Island University Hospital, Staten Island, New York 10305, United States
CCOP - Hematology-Oncology Associates of Central New York, Syracuse, New York 13057, United States
Community General Hospital of Greater Syracuse, Syracuse, New York 13215, United States
Faxton Regional Cancer Center, Utica, New York 13502, United States
Mission Hospitals - Memorial Campus, Asheville, North Carolina 28801, United States
Duke Comprehensive Cancer Center, Durham, North Carolina 27710, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina 27534, United States
Pardee Memorial Hospital, Hendersonville, North Carolina 28791, United States
Lenoir Memorial Cancer Center, Kinston, North Carolina 28501, United States
Moore Regional Community Hospital Comprehensive Cancer Center, Pinehurst, North Carolina 28374, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio 43210-1240, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital, Pittsburgh, Pennsylvania 15224-1791, United States
Miriam Hospital at Lifespan, Providence, Rhode Island 02906, United States
Rhode Island Hospital, Providence, Rhode Island 02903, United States
Women and Infants Hospital of Rhode Island, Providence, Rhode Island 02905, United States
CCOP - Greenville, Greenville, South Carolina 29615, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas 75390, United States
Southwestern Vermont Regional Cancer Center, Bennington, Vermont 05201, United States
Mountainview Medical, Berlin, Vermont 05602, United States
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont 05401, United States
Community Cancer Center at Rutland Regional Medical Center, Rutland, Vermont 05701, United States
Danville Regional Medical Center, Danville, Virginia 24541, United States
St. Mary's Regional Cancer Center at St. Mary's Medical Center, Huntington, West Virginia 25702, United States