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

Information source: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer; Osteoporosis

Intervention: calcium salts (Dietary Supplement); cholecalciferol (Dietary Supplement); zoledronic acid (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Alliance for Clinical Trials in Oncology

Official(s) and/or principal investigator(s):
Charles L. Shapiro, MD, Study Chair, Affiliation: Ohio State University Comprehensive Cancer Center

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Bone mineral density in the lumbar spine

Secondary outcome: Bone mineral density in the lumbar spine

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

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

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

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: December 2001
Last updated: September 26, 2013

Page last updated: August 23, 2015

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