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

Last updated: July 15, 2016
Sponsor: Alliance for Clinical Trials in Oncology
Overall Status: Completed

Phase

3

Condition

Breast Cancer

Osteoporosis

Cancer

Treatment

N/A

Clinical Study ID

NCT00022087
CALGB-79809
NCI-P01-0184
U10CA031946
CDR0000068781
CALGB-79809
  • Ages > 40
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 439
Study Start date:
December 01, 2001
Estimated Completion Date:
February 28, 2009

Study 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.

Connect with a study center

  • Arroyo Grande Community Hospital

    Arroyo Grande, California 93420
    United States

    Site Not Available

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California 92093-0658
    United States

    Site Not Available

  • El Camino Hospital

    Mountain View, California 94040
    United States

    Site Not Available

  • Naval Medical Center - San Diego

    San Diego, California 92134
    United States

    Site Not Available

  • Veterans Affairs Medical Center - San Diego

    San Diego, California 92161
    United States

    Site Not Available

  • Kent General Hospital at Bayhealth Medical Center

    Dover, Delaware 19901
    United States

    Site Not Available

  • Beebe Medical Center

    Lewes, Delaware 19958
    United States

    Site Not Available

  • CCOP - Christiana Care Health Services

    Newark, Delaware 19713
    United States

    Site Not Available

  • St. Francis Hospital

    Wilmington, Delaware 19805
    United States

    Site Not Available

  • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Sibley Memorial Hospital

    Washington, District of Columbia 20016
    United States

    Site Not Available

  • Washington Cancer Institute at Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida 33458
    United States

    Site Not Available

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Cancer Research Network, Incorporated

    Plantation, Florida 33324
    United States

    Site Not Available

  • Cleveland Clinic Florida - Weston

    Weston, Florida 33331
    United States

    Site Not Available

  • St. Joseph Medical Center

    Bloomington, Illinois 61701
    United States

    Site Not Available

  • Graham Hospital

    Canton, Illinois 61520
    United States

    Site Not Available

  • Memorial Hospital

    Carthage, Illinois 62321
    United States

    Site Not Available

  • University of Chicago Cancer Research Center

    Chicago, Illinois 60637-1470
    United States

    Site Not Available

  • Eureka Community Hospital

    Eureka, Illinois 61530
    United States

    Site Not Available

  • Galesburg Clinic

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Galesburg Cottage Hospital

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • InterCommunity Cancer Center of Western Illinois

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Mason District Hospital

    Havana, Illinois 62644
    United States

    Site Not Available

  • Hopedale Medical Complex

    Hopedale, Illinois 61747
    United States

    Site Not Available

  • Kewanee Hospital

    Kewanee, Illinois 61443
    United States

    Site Not Available

  • La Grange Memorial Hospital

    La Grange, Illinois 60525
    United States

    Site Not Available

  • McDonough District Hospital

    Macomb, Illinois 61455
    United States

    Site Not Available

  • BroMenn Regional Medical Center

    Normal, Illinois 61761
    United States

    Site Not Available

  • Community Cancer Center

    Normal, Illinois 61761
    United States

    Site Not Available

  • Advocate Christ Medical Center

    Oak Lawn, Illinois 60453-2699
    United States

    Site Not Available

  • Community Hospital of Ottawa

    Ottawa, Illinois 61350
    United States

    Site Not Available

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois 61554
    United States

    Site Not Available

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Methodist Medical Center of Illinois

    Peoria, Illinois 61636
    United States

    Site Not Available

  • OSF St. Francis Medical Center

    Peoria, Illinois 61637
    United States

    Site Not Available

  • Oncology/Hematology Associates of Central Illinois, P.C.

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Proctor Hospital

    Peoria, Illinois 61614
    United States

    Site Not Available

  • Illinois Valley Community Hospital

    Peru, Illinois 61354
    United States

    Site Not Available

  • Perry Memorial Hospital

    Princeton, Illinois 61356
    United States

    Site Not Available

  • St. Margaret's Hospital

    Spring Valley, Illinois 61362
    United States

    Site Not Available

  • Valley Cancer Center

    Spring Valley, Illinois 61362
    United States

    Site Not Available

  • Elkhart General Hospital

    Elkhart, Indiana 46515
    United States

    Site Not Available

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana 46350
    United States

    Site Not Available

  • Suniti Medical Corporation

    Merrillville, Indiana 46410
    United States

    Site Not Available

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana 46601
    United States

    Site Not Available

  • Memorial Hospital of South Bend

    South Bend, Indiana 46601
    United States

    Site Not Available

  • Saint Joseph Regional Medical Center

    South Bend, Indiana 46617
    United States

    Site Not Available

  • Hematology Oncology Associates of the Quad Cities

    Bettendorf, Iowa 52722
    United States

    Site Not Available

  • Iowa Blood and Cancer Care

    Cedar Rapids, Iowa 52402
    United States

    Site Not Available

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa 52403
    United States

    Site Not Available

  • St. Luke's Hospital

    Cedar Rapids, Iowa 52402
    United States

    Site Not Available

  • Central Maine Medical Center

    Lewiston, Maine 04240
    United States

    Site Not Available

  • Maine Center for Cancer Medicine and Blood Disorders - Scarborough

    Scarborough, Maine 04074
    United States

    Site Not Available

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

    Baltimore, Maryland 21237
    United States

    Site Not Available

  • Union Hospital Cancer Center at Union Hospital

    Elkton MD, Maryland 21921
    United States

    Site Not Available

  • Sturdy Memorial Hospital

    Attleboro, Massachusetts 02703
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Faulkner Hospital

    Boston, Massachusetts 02130
    United States

    Site Not Available

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Bethke Cancer Center at Emerson Hospital

    Concord, Massachusetts 01742
    United States

    Site Not Available

  • Lowell General Hospital

    Lowell, Massachusetts 01854
    United States

    Site Not Available

  • Fairview University Medical Center - University Campus

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Saint Luke's Hospital

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • CCOP - Kansas City

    Kansas City, Missouri 64131
    United States

    Site Not Available

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri 63110
    United States

    Site Not Available

  • Missouri Baptist Cancer Center

    St. Louis, Missouri 63131
    United States

    Site Not Available

  • Missouri Cancer Care, P. C. - Wentzville

    Wentzville, Missouri 63385
    United States

    Site Not Available

  • Methodist Cancer Center at Methodist Hospital - Omaha

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • New Hampshire Oncology-Hematology, PA - Hooksett

    Hooksett, New Hampshire 03106
    United States

    Site Not Available

  • Lakes Region General Hospital

    Laconia, New Hampshire 03246
    United States

    Site Not Available

  • Elliot Regional Cancer Center

    Manchester, New Hampshire 03103
    United States

    Site Not Available

  • Oncology Center at St. Joseph Hospital

    Nashua, New Hampshire 03060
    United States

    Site Not Available

  • Jersey City Medical Center at Liberty Health

    Jersey City, New Jersey 07302
    United States

    Site Not Available

  • Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263-0001
    United States

    Site Not Available

  • Memorial Sloan-Kettering Cancer Center

    New York, New York 10021
    United States

    Site Not Available

  • Nalitt Cancer Institute at Staten Island University Hospital

    Staten Island, New York 10305
    United States

    Site Not Available

  • CCOP - Hematology-Oncology Associates of Central New York

    Syracuse, New York 13057
    United States

    Site Not Available

  • Community General Hospital of Greater Syracuse

    Syracuse, New York 13215
    United States

    Site Not Available

  • Faxton Regional Cancer Center

    Utica, New York 13502
    United States

    Site Not Available

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Duke Comprehensive Cancer Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina 27534
    United States

    Site Not Available

  • Pardee Memorial Hospital

    Hendersonville, North Carolina 28791
    United States

    Site Not Available

  • Lenoir Memorial Cancer Center

    Kinston, North Carolina 28501
    United States

    Site Not Available

  • Moore Regional Community Hospital Comprehensive Cancer Center

    Pinehurst, North Carolina 28374
    United States

    Site Not Available

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio 43210-1240
    United States

    Site Not Available

  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania 15224-1791
    United States

    Site Not Available

  • Miriam Hospital at Lifespan

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Women and Infants Hospital of Rhode Island

    Providence, Rhode Island 02905
    United States

    Site Not Available

  • CCOP - Greenville

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas 75390
    United States

    Site Not Available

  • Southwestern Vermont Regional Cancer Center

    Bennington, Vermont 05201
    United States

    Site Not Available

  • Mountainview Medical

    Berlin, Vermont 05602
    United States

    Site Not Available

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Community Cancer Center at Rutland Regional Medical Center

    Rutland, Vermont 05701
    United States

    Site Not Available

  • Danville Regional Medical Center

    Danville, Virginia 24541
    United States

    Site Not Available

  • St. Mary's Regional Cancer Center at St. Mary's Medical Center

    Huntington, West Virginia 25702
    United States

    Site Not Available

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