Spots Global Cancer Trial Database for An Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) in Patients With Breast Cancer
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Trial Identification
Brief Title: An Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) in Patients With Breast Cancer
Official Title: A 24-Week Blinded Study Conducted at Multiple Centers, Evaluating the Safety and Effectiveness of Various Doses of the Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) When Randomly Assigned to Patients With Breast Cancer That Has Metastasized to Bone
Study ID: NCT00051779
Interventions
Study Description
Brief Summary: This study is intended to evaluate the safety, tolerability, and possible effectiveness of an investigational humanized monoclonal antibody (CAL) to the parathyroid hormone-related protein (PTHrP) when compared to zoledronic acid in patients with breast cancer metastatic to bone. The study will also evaluate the possible effects of both study drugs on performance status, markers of bone metabolism, and skeletal events related to bone metastasis including elevated blood calcium levels, bone pain, metastatic lesions, complications and interventions. The levels of CAL in the blood will also be evaluated.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Highlands Oncology Group, Springdale, Arkansas, United States
Bay Area Cancer Research Group, Concord, California, United States
California Cancer Care, Inc., Greenbrae, California, United States
Institute of Cancer Therapies, Los Angeles, California, United States
San Diego Cancer Research Institute, Vista, California, United States
Anschutz Cancer Pavilion at the University of Colorado Cancer Center, Aurora, Colorado, United States
Yale University, New Haven, Connecticut, United States
Holy Cross Hospital, Ft. Lauderdale, Florida, United States
Rush Cancer Institute, Chicago, Illinois, United States
University of Kentucky Medical Center, Lexington, Kentucky, United States
Louisiana State University, New Orleans, Louisiana, United States
Frederick Memorial Hospital, Frederick, Maryland, United States
Dana-Farber/Harvard Cancer Center, Boston, Massachusetts, United States
Josephine Ford Cancer Center, Detroit, Michigan, United States
Spectrum Health, Grand Rapids, Michigan, United States
Southfield Oncology Institute, Inc., Southfield, Michigan, United States
St. Louis Center for Clinical Research, St. Louis, Missouri, United States
Nevada Cancer Center, Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
New Mexico Cancer Care Associates, Santa Fe, New Mexico, United States
Montefiore Medical Center, Bronx, New York, United States
HemOnCare, P.C., Brooklyn, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Ireland Cancer Center, Cleveland, Ohio, United States
University Hospitals of Cleveland, Cleveland, Ohio, United States
Hematology Oncology Consultants, Inc., Columbus, Ohio, United States
Penn State Hershey Medical Center, Hershey, Pennsylvania, United States
Palmetto Health, Columbia, South Carolina, United States
Boston Baskin Cancer Group, Memphis, Tennessee, United States
The Boston Baskin Cancer Group, Memphis, Tennessee, United States
The West Clinic, Memphis, Tennessee, United States
Cancer Specialists of South Texas, PA, Corpus Christi, Texas, United States
Center for Oncology Research & Treatment, Dallas, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
Medical College of Wisconsin-FMLH East Neoplastic Diseases and Related Disorders, Milwaukee, Wisconsin, United States
Contact Details
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