Prospective Study of Tumor Response Assessment in Metastatic Breast Cancer Involving Bones

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. MRI and PET/CT can be performed if they are needed by standard of care. We anticipate MRI will be performed most commonly due to back pain.

Researchers will also compare three sets of standardized evaluation criteria (UICC criteria, WHO criteria, MDACC criteria). The MDACC criteria are new while the UICC and the WHO are standard criteria. The old criteria are no longer thought to be as reliable because they are based only on older technology (XR and SS). Since newer technologies are not included in the old criteria, most cancer doctors do not use these older criteria for evaluation of bone lesions. Therefore, new bone tumor criteria including newer imaging techniques (CT and MRI) are needed. At the end of the study, researchers will look at how sensitive and clear each imaging technique is, and they will use a set of criteria to learn which technique best measures the disease's response to therapy.

Participants in this study will have a complete physical exam, including a score of their bone pain. Routine blood tests (between 1-2 tablespoons) will be performed before participation in this study begins. Women who are able to have children must have a negative blood pregnancy test before starting treatment.

Participants will also have imaging examinations (XR, SS, CT, and MRI, PET/CT).

All of the first examinations will be finished within one month before the start the anti-cancer therapy. If imaging examinations alone cannot prove that the disease has spread to the bone, a needle bone biopsy will be done. A bone biopsy means that researchers will collect a couple of small tumor samples from the suspicious bone site. The tumor samples will be taken using a large needle while you are under the appropriate anesthesia.