Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Major Inclusion Criteria - Others Stipulated within the Protocol

The study physician must assure you have/are:

Must be a female at least 18 years of age and be using an effective form of birth control.
A documented history of breast cancer and at least one bone metastasis that has not been previously treated by radiation or surgery, and is not anticipated to be treated within the next 24 weeks.
A total body bone scan and other radiographic scan(s) performed on you within 4 weeks prior to or during the screening period sufficient to image all sites of bone metastases.
You must be willing to perform a daily telephone diary and be willing to keep a paper diary and provide voluntary consent to participate in this study.

Major Exclusion Criteria - Others Stipulated within the Protocol

The study physician must assure you do not have/are not:

A change in analgesic (pain relief) type medication during the screening period (example, non-narcotic to narcotic).
Received radiation therapy to any bone metastasis or started a new course of chemotherapy within 3 weeks prior to the screening visit or during the screening period.
Used any bisphosphonate type drug during the 30 days prior to the anticipated first dose of study drug
Vertebral spine or weight-bearing bone metastasis that would place you at imminent risk for fracture or surgical intervention.
Evidence of active infection or immune deficiency, renal failure, abnormal liver function, or a serum calcium level > 10.1 mg/dL.
Use of any investigational drug within 30 days prior to screening.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Study ID:

NCT00051779

Recruitment Status:

Completed

Sponsor:

Chugai Pharma USA

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There are 35 Locations for this study

See Locations Near You

University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Highlands Oncology Group
Springdale Arkansas, 72764, United States
Bay Area Cancer Research Group
Concord California, 94520, United States
California Cancer Care, Inc.
Greenbrae California, 94904, United States
Institute of Cancer Therapies
Los Angeles California, , United States
San Diego Cancer Research Institute
Vista California, 92083, United States
Anschutz Cancer Pavilion at the University of Colorado Cancer Center
Aurora Colorado, 80010, United States
Yale University
New Haven Connecticut, 06520, United States
Holy Cross Hospital
Ft. Lauderdale Florida, 33308, United States
Rush Cancer Institute
Chicago Illinois, 60612, United States
University of Kentucky Medical Center
Lexington Kentucky, 40536, United States
Louisiana State University
New Orleans Louisiana, 70112, United States
Frederick Memorial Hospital
Frederick Maryland, 21701, United States
Dana-Farber/Harvard Cancer Center
Boston Massachusetts, 02115, United States
Josephine Ford Cancer Center
Detroit Michigan, 48202, United States
Spectrum Health
Grand Rapids Michigan, 49503, United States
Southfield Oncology Institute, Inc.
Southfield Michigan, 48076, United States
St. Louis Center for Clinical Research
St. Louis Missouri, 63128, United States
Nevada Cancer Center
Las Vegas Nevada, 89109, United States
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
New Mexico Cancer Care Associates
Santa Fe New Mexico, 87505, United States
Montefiore Medical Center
Bronx New York, 10467, United States
HemOnCare, P.C.
Brooklyn New York, 11235, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10021, United States
SUNY Upstate Medical University
Syracuse New York, 12310, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States
University Hospitals of Cleveland
Cleveland Ohio, 44106, United States
Hematology Oncology Consultants, Inc.
Columbus Ohio, 43235, United States
Penn State Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Palmetto Health
Columbia South Carolina, 29203, United States
Boston Baskin Cancer Group
Memphis Tennessee, 38104, United States
The Boston Baskin Cancer Group
Memphis Tennessee, 38104, United States
The West Clinic
Memphis Tennessee, 38120, United States
Cancer Specialists of South Texas, PA
Corpus Christi Texas, 78412, United States
Center for Oncology Research & Treatment
Dallas Texas, 75230, United States
Baylor College of Medicine
Houston Texas, 77030, United States
Medical College of Wisconsin-FMLH East Neoplastic Diseases and Related Disorders
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Study ID:

NCT00051779

Recruitment Status:

Completed

Sponsor:


Chugai Pharma USA

How clear is this clinincal trial information?

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