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

July 15, 2016 updated by: Alliance for Clinical Trials in Oncology

Phase III Trial of Intravenous Zoledronic Acid (Zometa) in the Prevention of Bone Loss in Localized Breast Cancer Patients With Chemotherapy-Induced Ovarian Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

439

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Zoledronic acid initial tx
Zoledronic acid + calcium + Vit D for 2 years, followed by Calcium + vit D for 1 year
Dietary supplement: calcium salts
1000 mg PO per day
Dietary supplement: cholecalciferol
400 IU PO per day
Other Names:
  • Vitamin D
Drug: 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 Names:
  • Zometa
EXPERIMENTAL: Calcium + Vit D initial Tx
Calcium + vitamin D for 1 year followed by zoledronic acid + calcium + vit D for 2 years
Dietary supplement: calcium salts
1000 mg PO per day
Dietary supplement: cholecalciferol
400 IU PO per day
Other Names:
  • Vitamin D
Drug: 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 Names:
  • Zometa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone mineral density in the lumbar spine
Time Frame: 12 months from randomization
12 months from randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Bone mineral density in the lumbar spine
Time Frame: 36 months post randomization
36 months post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Primary Completion (ACTUAL)

March 1, 2007

Study Completion (ACTUAL)

February 1, 2009

Study Registration Dates

First Submitted

August 10, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALGB-79809
  • U10CA031946 (U.S. NIH Grant/Contract)
  • NCI-P01-0184
  • CDR0000068781 (REGISTRY: NCI Physicians Data Query)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on calcium salts

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe