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 3
40 Years
N/A
40 Years
N/A
Not Enrolling
Female
Breast Cancer, Osteoporosis
Female
Breast Cancer, Osteoporosis
Trial Information
Phase III Trial of Intravenous Zoledronic Acid (Zometa) in the Prevention of Bone Loss in Localized Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast by fine needle aspirate, biopsy
(tru-cut, core, stereotactic), lumpectomy, or modified radical mastectomy
- Stage I-III (any T, any N, M0)
- Stage IV due solely to supraclavicular node involvement allowed
- Plan to use adjuvant chemotherapy* with or without adjuvant endocrine therapy*
- Subsequent adjuvant hormonal therapy with an aromatase inhibitor allowed in
women rendered postmenopausal by adjuvant chemotherapy NOTE: *Must be specified
prior to study entry
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 40 and over
Sex:
- Female
Menopausal status:
- See Disease Characteristics
- Premenopausal, defined as actively menstruating or last menstrual period occurred
within 6 months prior to study entry
- Prior hysterectomy without bilateral oophorectomy and estradiol and
follicle-stimulating hormone within premenopausal range prior to the initiation
of chemotherapy allowed
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No more than 3 months since prior adjuvant chemotherapy
Endocrine therapy:
- See Disease Characteristics
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
- See Menopausal status
Other:
- No other concurrent bisphosphonates
- No concurrent digoxin
- No concurrent tetracycline
- Concurrent neoadjuvant therapy allowed
- Concurrent enrollment on therapeutic adjuvant clinical trials allowed provided the
therapeutic trial does not preclude participation in this trial
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Bone mineral density in the lumbar spine
Outcome Time Frame:
12 months from randomization
Safety Issue:
No
Principal Investigator
Charles L. Shapiro, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Ohio State University Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000068781
NCT ID:
NCT00022087
Start Date:
December 2001
Completion Date:
February 2009
Related Keywords:
- Breast Cancer
- Osteoporosis
- osteoporosis
- stage I breast cancer
- stage II breast cancer
- stage IV breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- Breast Neoplasms
- Osteoporosis
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Rhode Island Hospital | Providence, Rhode Island 02903 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
| Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
| Memorial Hospital of South Bend | South Bend, Indiana 46601 |
| Elliot Regional Cancer Center | Manchester, New Hampshire 03103 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
| Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
| Naval Medical Center - San Diego | San Diego, California 92134-3202 |
| Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Veterans Affairs Medical Center - San Diego | San Diego, California 92161 |
| Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
| Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough, Maine 04074 |
| Washington Cancer Institute at Washington Hospital Center | Washington, District of Columbia 20010 |
| Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center | Baltimore, Maryland 21237 |
| Fairview University Medical Center - University Campus | Minneapolis, Minnesota 55455 |
| Women and Infants Hospital of Rhode Island | Providence, Rhode Island 02905 |
| Advocate Christ Medical Center | Oak Lawn, Illinois 60453 |
| Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
| Sibley Memorial Hospital | Washington, District of Columbia 20016 |
| Hematology Oncology Associates of the Quad Cities | Bettendorf, Iowa 52722 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
| New Hampshire Oncology-Hematology, PA - Hooksett | Hooksett, New Hampshire 03106 |
| Memorial Cancer Institute at Memorial Regional Hospital | Hollywood, Florida 33021 |
| Lenoir Memorial Cancer Center | Kinston, North Carolina 28503-1678 |
| Miriam Hospital at Lifespan | Providence, Rhode Island 02906 |
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
| CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
| Brigham and Women's Hospital | Boston, Massachusetts 02115 |
| Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
| Elkhart General Hospital | Elkhart, Indiana 46515 |
| University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
| Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees | Camden, New Jersey 08103 |
| Beebe Medical Center | Lewes, Delaware 19958 |
| St. Francis Hospital | Wilmington, Delaware 19805 |
| Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
| Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
| St. Joseph Medical Center | Bloomington, Illinois 61701 |
| Graham Hospital | Canton, Illinois 61520 |
| Memorial Hospital | Carthage, Illinois 62321 |
| Eureka Community Hospital | Eureka, Illinois 61530 |
| Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
| Galesburg Clinic | Galesburg, Illinois 61401 |
| InterCommunity Cancer Center of Western Illinois | Galesburg, Illinois 61401 |
| Mason District Hospital | Havana, Illinois 62644 |
| Hopedale Medical Complex | Hopedale, Illinois 61747 |
| Kewanee Hospital | Kewanee, Illinois 61443 |
| McDonough District Hospital | Macomb, Illinois 61455 |
| BroMenn Regional Medical Center | Normal, Illinois 61761 |
| Community Cancer Center | Normal, Illinois 61761 |
| Community Hospital of Ottawa | Ottawa, Illinois 61350 |
| Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
| OSF St. Francis Medical Center | Peoria, Illinois 61637 |
| Proctor Hospital | Peoria, Illinois 61614 |
| Illinois Valley Community Hospital | Peru, Illinois 61354 |
| Perry Memorial Hospital | Princeton, Illinois 61356 |
| St. Margaret's Hospital | Spring Valley, Illinois 61362 |
| Valley Cancer Center | Spring Valley, Illinois 61362 |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
| St. Luke's Hospital | Cedar Rapids, Iowa 52402 |
| Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
| Union Hospital Cancer Center at Union Hospital | Elkton MD, Maryland 21921 |
| Sturdy Memorial Hospital | Attleboro, Massachusetts 02703 |
| Community General Hospital of Greater Syracuse | Syracuse, New York 13215 |
| Southwestern Vermont Regional Cancer Center | Bennington, Vermont 05201 |
| Mountainview Medical | Berlin, Vermont 05602 |
| Danville Regional Medical Center | Danville, Virginia 24541 |
| Faulkner Hospital | Jamaica Plain, Massachusetts 02130 |
| Central Maine Medical Center | Lewiston, Maine 04240 |
| Bethke Cancer Center at Emerson Hospital | Concord, Massachusetts 01742 |
| Saint Luke's Hospital | Chesterfield, Missouri 63017 |
| Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224-1791 |
| Methodist Cancer Center at Methodist Hospital - Omaha | Omaha, Nebraska 68114 |
| Lowell General Hospital | Lowell, Massachusetts 01854 |
| Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
| Moore Regional Community Hospital Comprehensive Cancer Center | Pinehurst, North Carolina 28374 |
| Community Cancer Center at Rutland Regional Medical Center | Rutland, Vermont 05701 |
| Nalitt Cancer Institute at Staten Island University Hospital | Staten Island, New York 10305 |
| La Grange Memorial Hospital | La Grange, Illinois 60525 |
| Lakes Region General Hospital | Laconia, New Hampshire 03246 |
| Iowa Blood and Cancer Care | Cedar Rapids, Iowa 52402 |
| Faxton Regional Cancer Center | Utica, New York 13502 |
| Arroyo Grande Community Hospital | Arroyo Grande, California 93420 |
| El Camino Hospital | Mountain View, California 94040 |
| Kent General Hospital at Bayhealth Medical Center | Dover, Delaware 19901 |
| Cancer Research Network, Incorporated | Plantation, Florida 33324 |
| Cleveland Clinic Florida - Weston | Weston, Florida 33331 |
| Suniti Medical Corporation | Merrillville, Indiana 46410 |
| Missouri Cancer Care, P. C. - Wentzville | Wentzville, Missouri 63385 |
| Oncology Center at St. Joseph Hospital | Nashua, New Hampshire 03060 |
| Jersey City Medical Center at Liberty Health | Jersey City, New Jersey 07302 |
| St. Mary's Regional Cancer Center at St. Mary's Medical Center | Huntington, West Virginia 25702 |
