Know Cancer

or
forgot password

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


Phase 3
40 Years
N/A
Not Enrolling
Female
Breast Cancer, Osteoporosis

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Bone mineral density in the lumbar spine

Outcome Time Frame:

12 months from randomization

Safety Issue:

No

Principal Investigator

Charles L. Shapiro, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000068781

NCT ID:

NCT00022087

Start Date:

December 2001

Completion Date:

February 2009

Related Keywords:

  • Breast Cancer
  • Osteoporosis
  • osteoporosis
  • stage I breast cancer
  • stage II breast cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms
  • Osteoporosis

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Chicago Cancer Research CenterChicago, Illinois  60637
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Rhode Island HospitalProvidence, Rhode Island  02903
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
Elliot Regional Cancer CenterManchester, New Hampshire  03103
CCOP - GreenvilleGreenville, South Carolina  29615
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Maine Center for Cancer Medicine and Blood Disorders - ScarboroughScarborough, Maine  04074
Washington Cancer Institute at Washington Hospital CenterWashington, District of Columbia  20010
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital CenterBaltimore, Maryland  21237
Fairview University Medical Center - University CampusMinneapolis, Minnesota  55455
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Advocate Christ Medical CenterOak Lawn, Illinois  60453
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Sibley Memorial HospitalWashington, District of Columbia  20016
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
New Hampshire Oncology-Hematology, PA - HooksettHooksett, New Hampshire  03106
Memorial Cancer Institute at Memorial Regional HospitalHollywood, Florida  33021
Lenoir Memorial Cancer CenterKinston, North Carolina  28503-1678
Miriam Hospital at LifespanProvidence, Rhode Island  02906
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Brigham and Women's HospitalBoston, Massachusetts  02115
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Elkhart General HospitalElkhart, Indiana  46515
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Cancer Institute of New Jersey at the Cooper University Hospital - VoorheesCamden, New Jersey  08103
Beebe Medical CenterLewes, Delaware  19958
St. Francis HospitalWilmington, Delaware  19805
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
InterCommunity Cancer Center of Western IllinoisGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Valley Cancer CenterSpring Valley, Illinois  61362
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
St. Luke's HospitalCedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
Union Hospital Cancer Center at Union HospitalElkton MD, Maryland  21921
Sturdy Memorial HospitalAttleboro, Massachusetts  02703
Community General Hospital of Greater SyracuseSyracuse, New York  13215
Southwestern Vermont Regional Cancer CenterBennington, Vermont  05201
Mountainview MedicalBerlin, Vermont  05602
Danville Regional Medical CenterDanville, Virginia  24541
Faulkner HospitalJamaica Plain, Massachusetts  02130
Central Maine Medical CenterLewiston, Maine  04240
Bethke Cancer Center at Emerson HospitalConcord, Massachusetts  01742
Saint Luke's HospitalChesterfield, Missouri  63017
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224-1791
Methodist Cancer Center at Methodist Hospital - OmahaOmaha, Nebraska  68114
Lowell General HospitalLowell, Massachusetts  01854
Pardee Memorial HospitalHendersonville, North Carolina  28791
Moore Regional Community Hospital Comprehensive Cancer CenterPinehurst, North Carolina  28374
Community Cancer Center at Rutland Regional Medical CenterRutland, Vermont  05701
Nalitt Cancer Institute at Staten Island University HospitalStaten Island, New York  10305
La Grange Memorial HospitalLa Grange, Illinois  60525
Lakes Region General HospitalLaconia, New Hampshire  03246
Iowa Blood and Cancer CareCedar Rapids, Iowa  52402
Faxton Regional Cancer CenterUtica, New York  13502
Arroyo Grande Community HospitalArroyo Grande, California  93420
El Camino HospitalMountain View, California  94040
Kent General Hospital at Bayhealth Medical CenterDover, Delaware  19901
Cancer Research Network, IncorporatedPlantation, Florida  33324
Cleveland Clinic Florida - WestonWeston, Florida  33331
Suniti Medical CorporationMerrillville, Indiana  46410
Missouri Cancer Care, P. C. - WentzvilleWentzville, Missouri  63385
Oncology Center at St. Joseph HospitalNashua, New Hampshire  03060
Jersey City Medical Center at Liberty HealthJersey City, New Jersey  07302
St. Mary's Regional Cancer Center at St. Mary's Medical CenterHuntington, West Virginia  25702