Breast Cancer Clinical Trial
Official title:
Prospective Study of Tumor Response Assessment in Metastatic Breast Cancer Involving Bones
Verified date | May 2012 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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 response of bone metastasis in patients with breast cancer.
- To estimate and compare the sensitivity and specificity of M. D. Anderson (MDACC) bone
metastasis criteria with that of current criteria (UICC, WHO) in breast cancer patients
for the assessment of the behavior of osseous metastasis in breast cancer patients.
Secondary Objective:
- To evaluate the progression free survival (PFS) and overall survival (OS) of each
response group (CR, PR, SD, PD) assessed by imaging and response criteria.
Status | Completed |
Enrollment | 37 |
Est. completion date | May 2012 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. 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) 2. Zubrod performance status 2 or less. (APPENDIX A) 3. Patient must receive systemic treatment (e.g., chemotherapy, hormonal therapy) for this newly diagnosed metastatic disease. (Additional bisphosphonate treatment will be acceptable.) 4. 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 Criteria: 1. Patients who have less than 3 months interval from completion of treatment (chemotherapy and/or radiation therapy) for primary breast cancer. 2. Patients who have the history of radiation therapy for bone disease. 3. History or presence of brain/leptomeningeal metastasis. 4. History of other malignancies except cured non-melanoma skin cancer or cured cervical carcinoma in situ |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | UT MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare different imaging techniques in measuring the response of bone disease to treatment. | 5 Years | No | |
Secondary | To compare different evaluation techniques (evaluation criteria) in reading the images. | 5 Years | No | |
Secondary | To study the change in the response of blood serum markers and the reliability of biochemical markers. | 5 Years | No |
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