Continued Efficacy and Safety of Zoledronic Acid (q 4 Wks vs. q 12 Wks) in the 2nd Year of Treatment in Patients With Bone Metastases From Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, zoledronic acid, bone metastases
Eligibility Criteria
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 have applied.
Sites / Locations
- Providence Alaska Medical Center Cancer Research
- Heritage Physicians Group Oncology
- The Center for Chest Care
- Pacific Cancer Medical Center, Inc.
- South Bay Oncology Hematology Partners
- Bay Area Cancer Research
- Pacific Coast Hem/Onc
- Wilshire Oncology Medical Group
- Kenmar Research Institute
- North Valley Hematology/Oncology Providence Holy Cross Medical
- Medical Oncology Care Associates
- Ventura County Hematology and Oncology
- The Office of Dr. Swarna Chanduri, MD
- Access Clinical Research
- Cancer and Blood of the Desert
- University of California Davis Cancer Center
- University of California at Los Angeles
- Denver Health Medical Center CACZ885M2301
- Eastern Connecticut Hematology & Oncology Associates
- Georgetown University/Lombardi Cancer Center
- Washington Hospital Center
- Baptist Cancer Center
- Pasco Hernando Oncology
- The Office of Dr. Elizabeth Tan-Chiu, MD PA
- Suburban Hematology-Oncology
- NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr
- Evanston Northwestern Healthcare Medical Group
- Edward Cancer Center
- Midwest Cancer Research Group
- Investigative Clinical Research
- Cancer Care Center
- Associated Physicians & Surgeons Clinic
- Medical Associates Clinic, PC
- University of Iowa Health Care
- Siouxland Hematology-Oncology Associates LLP
- Cotton O'Neil Oncology Clinic
- Cancer Center of Kansas
- Kentucky Lung Clinic & Kentucky Sleep Clinic
- Lexington Oncology Associates
- Cabrini Center for Cancer Care
- Southwest Oncology Associates Ltd.
- Greenbaum Cancer Center
- St. Agnes Hospital
- The Harry and Jeanette Weinberg Cancer Institute at Franklin
- Center for Cancer & Blood Disorders
- Frederick Memorial Hospital
- Caritas Holy Family Hospital
- University of Michigan Clinical Trials Office
- Wayne State University
- Henry Ford Hospital Oncology
- Oncology Care Associates, PLLC
- St. Luke's Hospital and Health Network
- Fairview Clinical Trial Services
- Univ. of Minnesota Cancer Center 420 Delaware St.
- Hubert H. Humphrey Cancer Center
- Jackson Oncology Associates
- Capitol Comprehensive Cancer Care Clinic
- The Center for Cancer Care and Research
- Nebraska Hematology-Oncology PC
- Nevada Cancer Centers 2851 North Tenaya Way
- Center for Cancer and Hematologic Disease
- Saint Barnabas Medical Center
- Somerset Hematology Oncology Associates
- Advanced Oncology Associates
- Arena Oncology Associates, PC
- Benedictine Hospital
- Beth Israel Medical Center
- Columbia Presbyterian Medical Center
- Memorial Sloan Kettering Cancer Center
- Jmaes P. Wilmot Cancer Center
- Alamance Regional Medical Cancer Center
- Northeast Oncology Associates Suite 250
- Barberton Citizens Hospital
- Gabrail Cancer Center
- Ohio Cancer Specialists
- Hematology/Oncology Consultants Inc.
- Trilogy Cancer Care
- Bay Area Hospital - Pharmacy
- The Corvallis Clinic, P.C.
- Milton S Hershey Medical Center
- Lancaster Cancer Center
- U of Pittsburgh Cancer Institute Magee-Womens Hospital
- Guthrie Cancer Center
- Mainline Oncology Hematology Assoc.
- M. Francisco Gonzalez, MD., FACP
- Santee Hematology/Oncology
- MD Anderson Cancer Center/University of Texas 1155 Herman Pressler Street
- Cancer Centers of South Texas
- Providence Everett Medical Clinic
- Seattle Cancer Care Alliance Seattle Cancer Care Alliance
- Rockwood Clinic Rockwood Clinic, PS
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Zoledronic acid every (q) 4 weeks
Zoledronic acid q 12 weeks
Placebo / zoledronic acid
Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were swithced to the zoledronic acid q 4 weeks according to a study amendment.