Bone Response in Metastatic Breast Cancer Involving Bones
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|ClinicalTrials.gov Identifier: NCT00420433|
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : February 19, 2016
- 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.
- 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.
|Condition or disease||Intervention/treatment|
|Breast Cancer Bone Metastases||Procedure: Skeletal Scintigraphy Procedure: Radiography Procedure: CT Scan|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||37 participants|
|Official Title:||Prospective Study of Tumor Response Assessment in Metastatic Breast Cancer Involving Bones|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||May 2012|
Patients with breast cancer that has spread to the bones.
Procedure: Skeletal Scintigraphy
Performed before treatment and again at 3, 6, 9, and 12 months after starting anticancer therapy.Procedure: Radiography
Performed before treatment and again at 3, 6, 9, and 12 months after starting anticancer therapy.
Other Name: X-RayProcedure: CT Scan
CT scan will include your chest, abdomen, and pelvis. Performed before treatment and again at 3, 6, 9, and 12 months after starting anticancer therapy.
Other Name: Computed Tomography
- To compare different imaging techniques in measuring the response of bone disease to treatment. [ Time Frame: 5 Years ]
- To compare different evaluation techniques (evaluation criteria) in reading the images. [ Time Frame: 5 Years ]
- To study the change in the response of blood serum markers and the reliability of biochemical markers. [ Time Frame: 5 Years ]
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): NCT00420433
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Naoto Ueno, MD, PhD||M.D. Anderson Cancer Center|