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Assessment of Tartrate-Resistant Acid Phosphatase (TRAP) as a Bone Resorption Marker in Stage IV Breast Cancer Patients With Bone Metastasis
This study has been completed.
First Received: December 9, 2005   Last Updated: June 1, 2007   History of Changes
Sponsors and Collaborators: James Graham Brown Cancer Center
University of Louisville
Information provided by: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT00264082
  Purpose

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 symptoms of bone metastases due to breast cancer. Tartrate-resistant acid phosphatase (TRAP) is a protein released into the blood stream as a result of bone destruction caused by metastasis of breast cancer to the bone. Bone destruction causes pain and bone fractures. This study will measure TRAP levels in serum taken from breast cancer patients to see if TRAP levels will be able to predict the effect of Zometa® treatment on bone destruction, pain and bone fractures.


Condition Intervention Phase
Breast Cancer
Drug: Zometa(drug)
Phase II

Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Retrospective/Prospective Study
Official Title:
  • Tartrate-Resistant Acid Phosphatase as a Bone Resorption Marker in Stage IV Breast Cancer Patients With Bone Metastasis During Zometa Treatment: A Pilot Study”

Resource links provided by NLM:


Further study details as provided by James Graham Brown Cancer Center:

Estimated Enrollment: 30
Study Start Date: September 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264082

Locations
United States, Kentucky
James Graham Brown Cancer Center, 529 S. Jackson St.
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
James Graham Brown Cancer Center
University of Louisville
Investigators
Principal Investigator: Leela Bhupalam, MD University of Louisville, James Graham Brown Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: 419.04
Study First Received: December 9, 2005
Last Updated: June 1, 2007
ClinicalTrials.gov Identifier: NCT00264082     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Zoledronic acid
Skin Diseases
Musculoskeletal Diseases
Bone Resorption
Neoplasm Metastasis
Breast Neoplasms
Bone Diseases
Breast Diseases

Additional relevant MeSH terms:
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Skin Diseases
Musculoskeletal Diseases
Bone Resorption
Neoplasm Metastasis
Breast Neoplasms
Bone Diseases
Breast Diseases

ClinicalTrials.gov processed this record on July 02, 2009