Zoledronate, Calcium, and Vitamin D in Preventing Bone Loss in Women Receiving Adjuvant Chemotherapy for Breast Cancer - Full Text View

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00022087

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Osteoporosis	Dietary Supplement: calcium carbonate Dietary Supplement: calcium citrate Dietary Supplement: cholecalciferol Drug: calcium gluconate Drug: zoledronic acid Procedure: adjuvant therapy	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control
Official Title:	Phase III Trial of Intravenous Zoledronic Acid (Zometa) in the Prevention of Bone Loss in Localized Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Calcium Cancer Dietary Supplements Diets Osteoporosis

Drug Information available for: Cholecalciferol Zoledronic acid Calcium gluconate Calcium carbonate Calcium citrate

U.S. FDA Resources

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

Primary Outcome Measures:

Bone mineral density in the lumbar spine after 12 and 36 months of therapy

Study Start Date:

December 2001

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022087

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Locations

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

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Charles L. Shapiro, MD

Arthur G. James Cancer Hospital & Richard J. Solove Research Institute

Study ID Numbers:	CDR0000068781, CALGB-79809, NCI-P01-0184
Study First Received:	August 10, 2001
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00022087 History of Changes
Health Authority:	United States: Federal Government