Bone Response in Metastatic Breast Cancer Involving Bones

Completed

Conditions studied: Breast Cancer, Bone Metastases

In brief

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.

Key facts

Study ID

NCT00420433

Run by

M.D. Anderson Cancer Center

People needed

37

Starts

2004-09-01

Expected to finish

2012-05-01

Last updated by the study team

2016-02-19

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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