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"Tartrate-Resistant Acid Phosphatase as a Bone Resorption Marker in Stage IV Breast Cancer Patients With Bone Metastasis During Zometa Treatment: A Pilot Study"


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

"Tartrate-Resistant Acid Phosphatase as a Bone Resorption Marker in Stage IV Breast Cancer Patients With Bone Metastasis During Zometa Treatment: A Pilot Study"


Inclusion Criteria:



1. Histologic or cytologic documentation of breast cancer.

2. Stage IV Breast Cancer Patients with bone metastasis for whom Zometa treatment will
be initiated.

3. Age > 18

4. Written informed consent prior to study entry

5. Patients may be currently receiving hormone therapy, chemotherapy and/or radiation
therapy to the primary tumor.

6. Life expectancy of at least 6 months.

7. We will include patients who have had previous or current radiation therapy to breast

Exclusion Criteria:

1. Concurrent malignancy with a second primary

2. Stage I, Stage II and Stage III

3. ECOG Performance Status 3 or 4.

4. Renal Failure - serum creatinine >2.O mg/dL at screening

5. AST or ALT > ULN X 3. at screening

6. Bilirubin > 3.0 mg/dL at screening

7. Pregnant women

8. Prior or current bisphosphonate therapy

9. Any skeletal related event due to malignancy prior to study enrollment.

10. Patients with osteoporotic fractures prior to study enrollment.

11. Allergy to bisphosphonates

12. Any radiation therapy for the treatment of bone metastases <4 weeks prior to study
start.

13. Any chronic medical condition which would preclude performance or adherence to
protocol requirements

14. Inability to provide informed consent

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Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Leela Bhupalam, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Louisville, James Graham Brown Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

419.04

NCT ID:

NCT00264082

Start Date:

September 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • Bone Resorption
  • Breast Neoplasms
  • Neoplasm Metastasis

Name

Location

James Graham Brown Cancer Center, 529 S. Jackson St. Louisville, Kentucky  40202