Zoledronate, Calcium, and Vitamin D in Preventing Bone Loss in Women Receiving Adjuvant Chemotherapy for Breast Cancer
NCT ID: NCT00022087
Last Updated: 2016-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
439 participants
INTERVENTIONAL
2001-12-31
2009-02-28
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Zoledronic acid initial tx
Zoledronic acid + calcium + Vit D for 2 years, followed by Calcium + vit D for 1 year
calcium salts
1000 mg PO per day
cholecalciferol
400 IU PO per day
zoledronic acid
4 mg IV infusion q 3 months, months 1-24 in Zoledronic acid initial tx arm and months 13-36 in calcium + vit D initial tx arm
Calcium + Vit D initial Tx
Calcium + vitamin D for 1 year followed by zoledronic acid + calcium + vit D for 2 years
calcium salts
1000 mg PO per day
cholecalciferol
400 IU PO per day
zoledronic acid
4 mg IV infusion q 3 months, months 1-24 in Zoledronic acid initial tx arm and months 13-36 in calcium + vit D initial tx arm
Interventions
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calcium salts
1000 mg PO per day
cholecalciferol
400 IU PO per day
zoledronic acid
4 mg IV infusion q 3 months, months 1-24 in Zoledronic acid initial tx arm and months 13-36 in calcium + vit D initial tx arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
40 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Charles L. Shapiro, MD
Role: STUDY_CHAIR
Ohio State University Comprehensive Cancer Center
Locations
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Arroyo Grande Community Hospital
Arroyo Grande, California, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
El Camino Hospital
Mountain View, California, United States
Naval Medical Center - San Diego
San Diego, California, United States
Veterans Affairs Medical Center - San Diego
San Diego, California, United States
Kent General Hospital at Bayhealth Medical Center
Dover, Delaware, United States
Beebe Medical Center
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
St. Francis Hospital
Wilmington, Delaware, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Washington Cancer Institute at Washington Hospital Center
Washington D.C., District of Columbia, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Cancer Research Network, Incorporated
Plantation, Florida, United States
Cleveland Clinic Florida - Weston
Weston, Florida, United States
St. Joseph Medical Center
Bloomington, Illinois, United States
Graham Hospital
Canton, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Eureka Community Hospital
Eureka, Illinois, United States
Galesburg Clinic
Galesburg, Illinois, United States
Galesburg Cottage Hospital
Galesburg, Illinois, United States
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, United States
Mason District Hospital
Havana, Illinois, United States
Hopedale Medical Complex
Hopedale, Illinois, United States
Kewanee Hospital
Kewanee, Illinois, United States
La Grange Memorial Hospital
La Grange, Illinois, United States
McDonough District Hospital
Macomb, Illinois, United States
BroMenn Regional Medical Center
Normal, Illinois, United States
Community Cancer Center
Normal, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Community Hospital of Ottawa
Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
OSF St. Francis Medical Center
Peoria, Illinois, United States
Illinois Valley Community Hospital
Peru, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
St. Margaret's Hospital
Spring Valley, Illinois, United States
Valley Cancer Center
Spring Valley, Illinois, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
Suniti Medical Corporation
Merrillville, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Saint Joseph Regional Medical Center
South Bend, Indiana, United States
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States
Iowa Blood and Cancer Care
Cedar Rapids, Iowa, United States
St. Luke's Hospital
Cedar Rapids, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States
Central Maine Medical Center
Lewiston, Maine, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland, United States
Union Hospital Cancer Center at Union Hospital
Elkton MD, Maryland, United States
Sturdy Memorial Hospital
Attleboro, Massachusetts, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
Faulkner Hospital
Boston, Massachusetts, United States
Bethke Cancer Center at Emerson Hospital
Concord, Massachusetts, United States
Lowell General Hospital
Lowell, Massachusetts, United States
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, United States
Saint Luke's Hospital
Chesterfield, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
Missouri Cancer Care, P. C. - Wentzville
Wentzville, Missouri, United States
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett, New Hampshire, United States
Lakes Region General Hospital
Laconia, New Hampshire, United States
Elliot Regional Cancer Center
Manchester, New Hampshire, United States
Oncology Center at St. Joseph Hospital
Nashua, New Hampshire, United States
Jersey City Medical Center at Liberty Health
Jersey City, New Jersey, United States
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
Voorhees Township, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Nalitt Cancer Institute at Staten Island University Hospital
Staten Island, New York, United States
CCOP - Hematology-Oncology Associates of Central New York
Syracuse, New York, United States
Community General Hospital of Greater Syracuse
Syracuse, New York, United States
Faxton Regional Cancer Center
Utica, New York, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Lenoir Memorial Cancer Center
Kinston, North Carolina, United States
Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Miriam Hospital at Lifespan
Providence, Rhode Island, United States
CCOP - Greenville
Greenville, South Carolina, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
Southwestern Vermont Regional Cancer Center
Bennington, Vermont, United States
Mountainview Medical
Berlin Corners, Vermont, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
Community Cancer Center at Rutland Regional Medical Center
Rutland, Vermont, United States
Danville Regional Medical Center
Danville, Virginia, United States
St. Mary's Regional Cancer Center at St. Mary's Medical Center
Huntington, West Virginia, United States
Countries
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References
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Shapiro CL, Halabi S, Gibson G, et al.: Effect of zoledronic acid (ZA) on bone mineral density (BMD) in premenopausal women who develop ovarian failure (OF) due to adjuvant chemotherapy (AdC): first results from CALGB trial 79809. [Abstract] J Clin Oncol 26 (Suppl 15): A-512, 2008.
Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
Other Identifiers
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CALGB-79809
Identifier Type: -
Identifier Source: secondary_id
NCI-P01-0184
Identifier Type: -
Identifier Source: secondary_id
CDR0000068781
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-79809
Identifier Type: -
Identifier Source: org_study_id
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