An Investigational Drug (CAL) Versus Zoledronic Acid (Zometa®) in Patients With Breast Cancer

Completed · Phase 1

Conditions studied: Breast Neoplasms, Breast Cancer, Metastasis

In brief

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.

Key facts

Study ID

NCT00051779

Run by

Chugai Pharma USA

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

Where it is running

• 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 — Fort 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
• 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
• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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