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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

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ClinicalTrials.gov Identifier: NCT00264082
Recruitment Status : Completed
First Posted : December 12, 2005
Last Update Posted : December 29, 2017
Sponsor:
Collaborator:
James Graham Brown Cancer Center
Information provided by (Responsible Party):
University of Louisville

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 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 or disease Intervention/treatment
Breast Cancer Drug: Zometa(drug)

Study Type : Observational
Estimated Enrollment : 30 participants
Time Perspective: Other
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"
Study Start Date : September 2004
Actual Primary Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer





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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264082


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

Additional Information:
Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT00264082     History of Changes
Other Study ID Numbers: 419.04
First Posted: December 12, 2005    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Breast Neoplasms
Bone Resorption
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bone Diseases
Musculoskeletal Diseases
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs