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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


Phase 1
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms, Breast Cancer, Metastasis

Thank you

Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

CAL-03

NCT ID:

NCT00051779

Start Date:

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • Breast Cancer
  • Metastasis
  • CAL
  • Parathyroid hormone-related protein (PTHrP)
  • Breast Cancer
  • Bone Metastasis
  • Hypercalcemia
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

Name

Location

Baylor College of MedicineHouston, Texas  77030
Louisiana State UniversityNew Orleans, Louisiana  70112-2282
Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Ireland Cancer CenterCleveland, Ohio  44106-5065
University Hospitals of ClevelandCleveland, Ohio  44106
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
California Cancer Care, Inc.Greenbrae, California  94904-2007
Southfield Oncology Institute, Inc.Southfield, Michigan  48076-3779
Montefiore Medical CenterBronx, New York  10467-2490
Nevada Cancer CenterLas Vegas, Nevada  89109
Rush Cancer InstituteChicago, Illinois  60612
HemOnCare, P.C.Brooklyn, New York  11235
Highlands Oncology GroupSpringdale, Arkansas  72764
New Mexico Cancer Care AssociatesSanta Fe, New Mexico  87505-7670
Boston Baskin Cancer GroupMemphis, Tennessee  38104
Duke University Medical CenterDurham, North Carolina  27710
SUNY Upstate Medical UniversitySyracuse, New York  13210
Holy Cross HospitalFort Lauderdale, Florida  33308
Yale UniversityNew Haven, Connecticut  06520
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
University of Kentucky Medical CenterLexington, Kentucky  40536-0093
Hematology Oncology Consultants, Inc.Columbus, Ohio  43235
Bay Area Cancer Research GroupConcord, California  94520
Cancer Specialists of South Texas, PACorpus Christi, Texas  78412
Institute of Cancer TherapiesLos Angeles, California  
San Diego Cancer Research InstituteVista, California  92083
Anschutz Cancer Pavilion at the University of Colorado Cancer CenterAurora, Colorado  80010-0510
Frederick Memorial HospitalFrederick, Maryland  21701
Dana-Farber/Harvard Cancer CenterBoston, Massachusetts  02115
Josephine Ford Cancer CenterDetroit, Michigan  48202
Spectrum HealthGrand Rapids, Michigan  49503
St. Louis Center for Clinical ResearchSt. Louis, Missouri  63128
Penn State Hershey Medical CenterHershey, Pennsylvania  17033
Palmetto HealthColumbia, South Carolina  29203
The West ClinicMemphis, Tennessee  38120
The Boston Baskin Cancer GroupMemphis, Tennessee  38104
Center for Oncology Research & TreatmentDallas, Texas  75230
Medical College of Wisconsin-FMLH East Neoplastic Diseases and Related DisordersMilwaukee, Wisconsin  53226