CompletedNot Applicable

Bone Response in Metastatic Breast Cancer Involving Bones

United States37 participantsStarted 2004-09

Plain-language 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 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.

Who can participate

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

To compare different imaging techniques in measuring the response of bone disease to treatment.

Timeframe: 5 Years

Trial details

NCT IDNCT00420433

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2008-10

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