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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
Open (Enrolling)
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

- 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:


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:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




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



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Caritas Holy Family Hospital Methuen, Massachusetts  01844
Suburban Hematology-Oncology Snellville, Georgia  30078-6782
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Cotton O'Neil Oncology Clinic Topeka, Kansas  66606
Cabrini Center for Cancer Care Alexandria, Louisiana  71301
LSU Health Sciences Center Shreveport, Louisiana  71130-3932
Cooper Cancer Center Voorhees, New Jersey  08043
The Jones Clinic Germantown, Tennessee  38138
Palo Verde Hematology & Oncology Glendale, Arizona  85304
SMDC Health System Duluth, Minnesota  55805
Sioux Valley Clinic Clinical Research Center Sioux Falls, South Dakota  57104
Center for Cancer & Blood Disorders Bethesda, Maryland  20817
Edward Cancer Center Naperville, Illinois  60540
Pasco Hernando Oncology New Port Richey, Florida  34652
University of Iowa Health Care Iowa City, Iowa  52242
Saint Barnabas Medical Center Livingston, New Jersey  07039
University of California at Los Angeles Los Angeles, California  90095
Cancer Center of Kansas Wichita, Kansas  67214
Rutland Regional Medical Center Rutland, Vermont  05701
Coastal Bend Cancer Center Corpus Christi, Texas  78404
The Center for Cancer Care and Research St. Louis, Missouri  63141
Medical Oncology LLC Baton Rouge, Louisiana  70809
South Bay Oncology Hematology Partners Campbell, California  95008
St. Agnes Hospital Baltimore, Maryland  21229
Pasco Hernando Oncology Associates, PA New Port Richey, Florida  34642
Jackson Oncology Associates Jackson, Mississippi  39202
Milton S Hershey Medical Center Hershey, Pennsylvania  17033
Cancer Research Network Plantation, Florida  33324
Osteopathic Medical Oncology and Hematology Clinton Township, Michigan  48037
Pacific Coast Hem/Onc Fountain Valley, California  92708
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Alaska Cancer Research & Education Center Anchorage, Alaska  99508
Associated Physicians & Surgeons Clinic Terre Haute, Indiana  47804
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Providence Alaska Medical Center Cancer Research Anchorage, Alaska  99508
Heritage Physicians Group Oncology Hot Springs, Arkansas  71913
The Center for Chest Care Springdale, Arkansas  72764
Pacific Cancer Medical Center, Inc. Anaheim, California  92801
Shapiro & Stafford & Yee & Polanski Arcadia, California  91007
Bay Area Cancer Research Concord, California  94520
Compassionate Cancer Care Medical Group 900 South Main Street Fountain Valley, California  92708
California Cancer Care Marian Speciality Greenbrae, California  94904
North Valley Hematology/Oncology Providence Holy Cross Medical Northridge, California  91328
Ventura County Hematology and Oncology Oxnard, California  93030
The Office of Dr. Swarna Chanduri, MD Pomona, California  91767
High Plains Oncology Pueblo, California  81004
Access Clinical Research Rancho Mirage, California  92270
Cancer and Blood of the Desert Rancho Mirage, California  92270
Kaiser Permanente San Diego San Diego, California  92108
Sant Chawla Inc Santa Monica, California  90403
Denver Health Medical Center CACZ885M2301 Denver, Colorado  80204-4507
Eastern Connecticut Hematology & Oncology Associates Norwich, Connecticut  06360
Georgetown University/Lombardi Cancer Center Washington, District of Columbia  20007-2197
Baptist Cancer Center Jacksonville, Florida  32209
Jupiter Medical Center-Clinical Research Office Jupiter, Florida  33458
Osler Medical Clinical Research Melbourne, Florida  32901
Cancer Research Network, Inc (CRN) Plantation, Florida  33324
Hematology Oncology Assoc of Central Brevard Rockledge, Florida  32955
The Office of Dr. Elizabeth Tan-Chiu, MD PA Tamarac, Florida  33321
H. Lee Moffitt Cancer Center/University of South Florida Hematology/Oncology Tampa, Florida  33613
Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2) Atlanta, Georgia  30322
Eisenhower Army Medical Center Room 8B40 Fort Gordon, Georgia  30905
NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Chicago, Illinois  60611
Evanston Northwestern Healthcare Medical Group Evanston, Illinois  60201
Mid Illinois Hematology Oncology Normal, Illinois  61761
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Medical Associates Clinic, PC Dubuque, Iowa  52001
Siouxland Hematology-Oncology Associates LLP Sioux City, Iowa  51101
Cedar Valley Medical Specialsts Waterloo, Iowa  50701
Kansas City Cancer Center KCCC Business Office Overland Park, Kansas  66210
Mowery Clinic LLC Tammy Walker Cancer Center Salina, Kansas  67401
Kentucky Lung Clinic & Kentucky Sleep Clinic Hazard, Kentucky  41701
Lexington Oncology Associates Lexington, Kentucky  40503
Southwest Oncology Associates Ltd. Lafayette, Louisiana  70503
Greenbaum Cancer Center Baltimore, Maryland  21201-1595
The Harry and Jeanette Weinberg Cancer Institute at Franklin Baltimore, Maryland  21237
Chesapeake Oncology Hematology Associates P.A. Glen Burnie, Maryland  21061
Calvert Memorial Hospital Prince Frederick, Maryland  20678
Kaiser Permanente - Maryland Rockville, Maryland  20850
University of Michigan Clinical Trials Office Ann Arbor, Michigan  48109
Henry Ford Hospital Oncology Detroit, Michigan  48202
Great Lakes Cancer Management Specialists Grosse Pointe Woods, Michigan  48236
Hematology Oncology Associates of Ohio & Michigan PC Lambertville, Michigan  48144
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Univ. of Minnesota Cancer Center 420 Delaware St. Minneapolis, Minnesota  55455
Fairview Clinical Trial Services Minneapolis, Minnesota  55414
St.Joseph Oncology INC Saint Joseph, Missouri  64507
Nebraska Hematology-Oncology PC Lincoln, Nebraska  68506
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Kingsbury Center for Cancer Care Keene, New Hampshire  03431
Essex Oncology of North Jersey PA Belleville, New Jersey  07109
UMDNJ ADMC 6 Room 625 Newark, New Jersey  07101
The Office of Dr. Parvez Dara, MD Toms River, New Jersey  08755
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Guthrie Cancer Center Corning, New York  14830
Arena Oncology Associates, PC Great Neck, New York  11021
Jmaes P. Wilmot Cancer Center Rochester, New York  14642
Alamance Regional Medical Cancer Center Burlington, North Carolina  27215
Northeast Oncology Associates Suite 250 Concord, North Carolina  28025
Physicians Associates, Inc. (Oncology Partner's Network) Oncology Partner's Network Cincinnati, Ohio  45238
Meridia Cancer Center Mayfield Heights, Ohio  44124
Hematology/Oncology Consultants Inc. West Worthington, Ohio  43235
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Bay Area Hospital - Pharmacy Coos Bay, Oregon  97420
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Conemaugh Cancer Care Center Johnstown, Pennsylvania  15905
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Guthrie Cancer Center Sayre, Pennsylvania  18840
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Lexington Oncology Associates West Columbia, South Carolina  29169
MD Anderson Cancer Center/University of Texas 1155 Herman Pressler Street Houston, Texas  77031
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Seattle Cancer Care Alliance Seattle Cancer Care Alliance Seattle, Washington  98109
Rockwood Clinic Rockwood Clinic, PS Spokane, Washington  99202
Greenbriar Oncology Clinic Lewisburg, West Virginia  24901
Morgantown Internal Medicine Morgantown, West Virginia  26505