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A Prospective, Randomized, Double-blind, Stratified, Multi-center, 2-arm Trial of the Continued Efficacy and Safety of Zoledronic Acid (Every 4 Weeks vs. Every 12 Weeks) in Patients With Documented Bone Metastases From Breast Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

Thank you

Trial Information

A Prospective, Randomized, Double-blind, Stratified, Multi-center, 2-arm Trial of the Continued Efficacy and Safety of Zoledronic Acid (Every 4 Weeks vs. Every 12 Weeks) in Patients With Documented Bone Metastases From Breast Cancer


Inclusion Criteria:



- Female patients ≥ 18 years of age

- Confirmed breast cancer with bone metastasis.

- Pretreated with Zometa®, or Aredia (pamidronate) or all sequential regimens of both,
for a minimum of 9 doses.

Exclusion Criteria:

- Abnormal kidney function determined by serum creatinine levels.

- Current active dental problems including: ongoing infection of the teeth or jawbone;
current exposed bone in the mouth; and current or prior diagnosis of osteonecrosis of
the jaw.

- Recent (within 8 weeks) or planned dental or jaw surgery (e.g., extraction, implants)

- Diagnosis of metabolic bone disease other than osteoporosis (e.g., Paget's disease of
bone)

- Known hypersensitivity to Zometa

- Treatment with other investigational drugs within 30 days prior to randomization.

Other protocol-defined exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Proportion of patients who experience at least one Skeletal Related Event (SRE) during the study period (SRE rate)

Outcome Time Frame:

during the study period

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CZOL446E2352

NCT ID:

NCT00320710

Start Date:

February 2006

Completion Date:

September 2013

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • zoledronic acid
  • bone metastases
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Medical College of WisconsinMilwaukee, Wisconsin  53226
Beth Israel Medical CenterNew York, New York  10003
Swedish Cancer InstituteSeattle, Washington  98104
University of California Davis Cancer CenterSacramento, California  95817
Capitol Comprehensive Cancer Care ClinicJefferson City, Missouri  65109
SUNY Downstate Medical CenterBrooklyn, New York  11203
Hubert H. Humphrey Cancer CenterCoon Rapids, Minnesota  55433
University of ColoradoDenver, Colorado  80217
Hattiesburg Clinic, P.A.Hattiesburg, Mississippi  39401
Center for Cancer And Hematologic DiseaseCherry Hill, New Jersey  08046
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Barberton Citizens HospitalBarberton, Ohio  44203
Cancer Care CenterNew Albany, Indiana  47150
Benedictine HospitalKingston, New York  12401
Washington Hospital CenterWashington, District of Columbia  20010
Oncology Care Associates, PLLCSaint Joseph, Michigan  49085
Medical Oncology Care AssociatesOrange, California  92668
Cancer Care AssociatesTulsa, Oklahoma  74136
Kenmar Research InstituteLos Angeles, California  90057
Lake Heart and Cancer Medical CenterLeesburg, Florida  34748
Queens Medical Associates, PCFresh Meadows, New York  11365
Advanced Oncology AssociatesArmonk, New York  10504
Comprehensive Cancer CenterGlendale, California  91204
Lancaster Cancer CenterLancaster, Pennsylvania  17604
Wayne State UniversityDetroit, Michigan  48202
Midwest Cancer Research GroupSkokie, Illinois  60077
Columbia Presbyterian Medical CenterNew York, New York  10032
Cancer Care AssociatesFresno, California  93720
Gabrail Cancer CenterCanton, Ohio  44718
California Oncology of the Central ValleyFresno, California  93710
Wilshire Oncology Medical GroupGlendora, California  91741
Clinical Trials and Research AssociatesMontebello, California  90640
Somerset Hematology Oncology AssociatesSomerset, New Jersey  08873
Santee Hematology/OncologySumter, South Carolina  29150
Frederick Memorial HospitalFrederick, Maryland  21701
Caritas Holy Family HospitalMethuen, Massachusetts  01844
Suburban Hematology-OncologySnellville, Georgia  30078-6782
Clinical Research Consultants, Inc.Hoover, Alabama  35216
Cotton O'Neil Oncology ClinicTopeka, Kansas  66606
Cabrini Center for Cancer CareAlexandria, Louisiana  71301
LSU Health Sciences CenterShreveport, Louisiana  71130-3932
Cooper Cancer CenterVoorhees, New Jersey  08043
The Jones ClinicGermantown, Tennessee  38138
Palo Verde Hematology & OncologyGlendale, Arizona  85304
SMDC Health SystemDuluth, Minnesota  55805
Sioux Valley Clinic Clinical Research CenterSioux Falls, South Dakota  57104
Center for Cancer & Blood DisordersBethesda, Maryland  20817
Edward Cancer CenterNaperville, Illinois  60540
Pasco Hernando OncologyNew Port Richey, Florida  34652
University of Iowa Health CareIowa City, Iowa  52242
Saint Barnabas Medical CenterLivingston, New Jersey  07039
University of California at Los AngelesLos Angeles, California  90095
Cancer Center of KansasWichita, Kansas  67214
Rutland Regional Medical CenterRutland, Vermont  05701
Coastal Bend Cancer CenterCorpus Christi, Texas  78404
The Center for Cancer Care and ResearchSt. Louis, Missouri  63141
Medical Oncology LLCBaton Rouge, Louisiana  70809
South Bay Oncology Hematology PartnersCampbell, California  95008
St. Agnes HospitalBaltimore, Maryland  21229
Pasco Hernando Oncology Associates, PANew Port Richey, Florida  34642
Jackson Oncology AssociatesJackson, Mississippi  39202
Milton S Hershey Medical CenterHershey, Pennsylvania  17033
Cancer Research NetworkPlantation, Florida  33324
Osteopathic Medical Oncology and HematologyClinton Township, Michigan  48037
Pacific Coast Hem/OncFountain Valley, California  92708
Ohio Cancer SpecialistsMansfield, Ohio  44907
Alaska Cancer Research & Education CenterAnchorage, Alaska  99508
Associated Physicians & Surgeons ClinicTerre Haute, Indiana  47804
Gulf Coast MBCCOPMobile, Alabama  36607
Providence Alaska Medical Center Cancer ResearchAnchorage, Alaska  99508
Heritage Physicians Group OncologyHot Springs, Arkansas  71913
The Center for Chest CareSpringdale, Arkansas  72764
Pacific Cancer Medical Center, Inc.Anaheim, California  92801
Shapiro & Stafford & Yee & PolanskiArcadia, California  91007
Bay Area Cancer ResearchConcord, California  94520
Compassionate Cancer Care Medical Group 900 South Main StreetFountain Valley, California  92708
California Cancer Care Marian SpecialityGreenbrae, California  94904
North Valley Hematology/Oncology Providence Holy Cross MedicalNorthridge, California  91328
Ventura County Hematology and OncologyOxnard, California  93030
The Office of Dr. Swarna Chanduri, MDPomona, California  91767
High Plains OncologyPueblo, California  81004
Access Clinical ResearchRancho Mirage, California  92270
Cancer and Blood of the DesertRancho Mirage, California  92270
Kaiser Permanente San DiegoSan Diego, California  92108
Sant Chawla IncSanta Monica, California  90403
Denver Health Medical Center CACZ885M2301Denver, Colorado  80204-4507
Eastern Connecticut Hematology & Oncology AssociatesNorwich, Connecticut  06360
Georgetown University/Lombardi Cancer CenterWashington, District of Columbia  20007-2197
Baptist Cancer CenterJacksonville, Florida  32209
Jupiter Medical Center-Clinical Research OfficeJupiter, Florida  33458
Osler Medical Clinical ResearchMelbourne, Florida  32901
Cancer Research Network, Inc (CRN)Plantation, Florida  33324
Hematology Oncology Assoc of Central BrevardRockledge, Florida  32955
The Office of Dr. Elizabeth Tan-Chiu, MD PATamarac, Florida  33321
H. Lee Moffitt Cancer Center/University of South Florida Hematology/OncologyTampa, Florida  33613
Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)Atlanta, Georgia  30322
Eisenhower Army Medical Center Room 8B40Fort Gordon, Georgia  30905
NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer CtrChicago, Illinois  60611
Evanston Northwestern Healthcare Medical GroupEvanston, Illinois  60201
Mid Illinois Hematology OncologyNormal, Illinois  61761
Investigative Clinical ResearchIndianapolis, Indiana  46254
Medical Associates Clinic, PCDubuque, Iowa  52001
Siouxland Hematology-Oncology Associates LLPSioux City, Iowa  51101
Cedar Valley Medical SpecialstsWaterloo, Iowa  50701
Kansas City Cancer Center KCCC Business OfficeOverland Park, Kansas  66210
Mowery Clinic LLC Tammy Walker Cancer CenterSalina, Kansas  67401
Kentucky Lung Clinic & Kentucky Sleep ClinicHazard, Kentucky  41701
Lexington Oncology AssociatesLexington, Kentucky  40503
Southwest Oncology Associates Ltd.Lafayette, Louisiana  70503
Greenbaum Cancer CenterBaltimore, Maryland  21201-1595
The Harry and Jeanette Weinberg Cancer Institute at FranklinBaltimore, Maryland  21237
Chesapeake Oncology Hematology Associates P.A.Glen Burnie, Maryland  21061
Calvert Memorial HospitalPrince Frederick, Maryland  20678
Kaiser Permanente - MarylandRockville, Maryland  20850
University of Michigan Clinical Trials OfficeAnn Arbor, Michigan  48109
Henry Ford Hospital OncologyDetroit, Michigan  48202
Great Lakes Cancer Management SpecialistsGrosse Pointe Woods, Michigan  48236
Hematology Oncology Associates of Ohio & Michigan PCLambertville, Michigan  48144
St. Luke's Hospital and Health NetworkDuluth, Minnesota  55805
Univ. of Minnesota Cancer Center 420 Delaware St.Minneapolis, Minnesota  55455
Fairview Clinical Trial ServicesMinneapolis, Minnesota  55414
St.Joseph Oncology INCSaint Joseph, Missouri  64507
Nebraska Hematology-Oncology PCLincoln, Nebraska  68506
Nevada Cancer Centers 2851 North Tenaya WayLas Vegas, Nevada  89109
Kingsbury Center for Cancer CareKeene, New Hampshire  03431
Essex Oncology of North Jersey PABelleville, New Jersey  07109
UMDNJ ADMC 6 Room 625Newark, New Jersey  07101
The Office of Dr. Parvez Dara, MDToms River, New Jersey  08755
New Mexico Oncology HematologyAlbuquerque, New Mexico  87109
Guthrie Cancer CenterCorning, New York  14830
Arena Oncology Associates, PCGreat Neck, New York  11021
Jmaes P. Wilmot Cancer CenterRochester, New York  14642
Alamance Regional Medical Cancer CenterBurlington, North Carolina  27215
Northeast Oncology Associates Suite 250Concord, North Carolina  28025
Physicians Associates, Inc. (Oncology Partner's Network) Oncology Partner's NetworkCincinnati, Ohio  45238
Meridia Cancer CenterMayfield Heights, Ohio  44124
Hematology/Oncology Consultants Inc.West Worthington, Ohio  43235
Trilogy Cancer CareWooster, Ohio  44691
Forum HealthYoungstown, Ohio  44501
Bay Area Hospital - PharmacyCoos Bay, Oregon  97420
The Corvallis Clinic, P.C.Corvallis, Oregon  97330
Patterson Cancer Care CenterCoudersport, Pennsylvania  16915
Conemaugh Cancer Care CenterJohnstown, Pennsylvania  15905
Rittenhouse Hemotology/OncologyPhiladelphia, Pennsylvania  19146
U of Pittsburgh Cancer Institute Magee-Womens HospitalPittsburgh, Pennsylvania  15213
Guthrie Cancer CenterSayre, Pennsylvania  18840
Mainline Oncology Hematology Assoc.Wynnewood, Pennsylvania  19096
Medical Associates, PACharleston, South Carolina  29403
M. Francisco Gonzalez, MD., FACPColumbia, South Carolina  29203
Lexington Oncology AssociatesWest Columbia, South Carolina  29169
MD Anderson Cancer Center/University of Texas 1155 Herman Pressler StreetHouston, Texas  77031
Cancer Centers of South TexasSan Antonio, Texas  78229
Community PracticeWoodbridge, Virginia  22191
Providence Everett Medical ClinicEverett, Washington  98201
Seattle Cancer Care Alliance Seattle Cancer Care AllianceSeattle, Washington  98109
Rockwood Clinic Rockwood Clinic, PSSpokane, Washington  99202
Greenbriar Oncology ClinicLewisburg, West Virginia  24901
Morgantown Internal MedicineMorgantown, West Virginia  26505