Status:
COMPLETED
Bone Response in Metastatic Breast Cancer Involving Bones
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Breast Cancer
Bone Metastases
Eligibility:
All Genders
Brief Summary
Primary Objectives: * To estimate and compare the sensitivity and specificity of computed tomography (CT), plain radiography (XR), and skeletal scintigraphy (SS) with each other for the assessment of...
Detailed Description
This study will compare plain x-rays (XR), skeletal scintigraphy (SS), computed tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography/CT (PET/CT) in measuring response. M...
Eligibility Criteria
Inclusion
- Newly diagnosed bone (from calvarium to pelvis include ribs and sternum) and nonosseous (it should be measurable by CT) metastasis or primary breast tumor (with a confirmation of no surgical treatment for 12 months) from breast cancer. If the bone metastasis is not confirmed by imaging, bone biopsy is needed. Please see diagnostic flow sheet. (APPENDIX B)
- Zubrod performance status 2 or less. (APPENDIX A)
- Patient must receive systemic treatment (e.g., chemotherapy, hormonal therapy) for this newly diagnosed metastatic disease. (Additional bisphosphonate treatment will be acceptable.)
- Patients must sign an informed consent document indicating awareness that this study is not focusing on the verification of treatment agents but on verification of modalities to assess bone tumor response, in keeping with institutional policy.
Exclusion
- Patients who have less than 3 months interval from completion of treatment (chemotherapy and/or radiation therapy) for primary breast cancer.
- Patients who have the history of radiation therapy for bone disease.
- History or presence of brain/leptomeningeal metastasis.
- History of other malignancies except cured non-melanoma skin cancer or cured cervical carcinoma in situ
Key Trial Info
Start Date :
September 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00420433
Start Date
September 1 2004
End Date
May 1 2012
Last Update
February 19 2016
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030