Status:
COMPLETED
Assessment of Tartrate-Resistant Acid Phosphatase (TRAP) as a Bone Resorption Marker in Stage IV Breast Cancer Patients With Bone Metastasis
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
James Graham Brown Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
The purpose of this research study is to evaluate the usefulness of the TRAP protein as (1) an early indicator of bone destruction and (2) a tool for assessing the effect of Zometa® in treating sympto...
Eligibility Criteria
Inclusion
- Histologic or cytologic documentation of breast cancer.
- Stage IV Breast Cancer Patients with bone metastasis for whom Zometa treatment will be initiated.
- Age \> 18
- Written informed consent prior to study entry
- Patients may be currently receiving hormone therapy, chemotherapy and/or radiation therapy to the primary tumor.
- Life expectancy of at least 6 months.
- We will include patients who have had previous or current radiation therapy to breast
Exclusion
- Concurrent malignancy with a second primary
- Stage I, Stage II and Stage III
- ECOG Performance Status 3 or 4.
- Renal Failure - serum creatinine \>2.O mg/dL at screening
- AST or ALT \> ULN X 3. at screening
- Bilirubin \> 3.0 mg/dL at screening
- Pregnant women
- Prior or current bisphosphonate therapy
- Any skeletal related event due to malignancy prior to study enrollment.
- Patients with osteoporotic fractures prior to study enrollment.
- Allergy to bisphosphonates
- Any radiation therapy for the treatment of bone metastases \<4 weeks prior to study start.
- Any chronic medical condition which would preclude performance or adherence to protocol requirements
- Inability to provide informed consent
- \-
Key Trial Info
Start Date :
September 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00264082
Start Date
September 1 2004
Last Update
December 29 2017
Active Locations (1)
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1
James Graham Brown Cancer Center, 529 S. Jackson St.
Louisville, Kentucky, United States, 40202