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Study Coordinator(s): Jeffrey B. Smerage, M.D. Ph.D., Daniel F. Hayes, M.D. Participants: Members, CCOP, Affiliates, Medical Oncologists, CTSU Institutions in the United States Eligibility Criteria: Women with histologically confirmed breast cancer and clinical evidence of Stage IV disease; must have measurable disease or bone-only disease (patients whose only disease is non-measurable disease that does not include bone are ineligible); must not have received any prior chemotherapy for metastatic disease; prior use of hormonal, bisphosphonate, trastuzumab, and/or bevacizumab in the metastatic setting is allowed; may have received any number or type of exogenous hormonal therapies, either for metastatic disease and/or adjuvant therapy; prior adjuvant chemotherapy must be completed at least 12 months prior to registration; must have recovered from any prior surgery; must consent to the CTC blood draw schedule as outlined in the protocol, and submit the initial blood draw within one day of registration; patients who are willing to have their serum banked must provide their consent as outlined in the protocol; PS=0-2; patients with brain metastases must have stable disease >90 days after completing radiotherapy; must not have leptomeningeal disease; pregnant or nursing women are not eligible; no prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, any adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
Required prestudy labs/scans:
<= 28 days prior to registration (measurable disease):
CT or MRI of the chest & abdomen; whole body bone scan or PET scan; any other x-rays, scans, or physical exams used for tumor measurement.
<=42 days prior to registration (non-measurable disease): X-rays, scan, or physical exams used for tumor assessment
**All patients must have HER-2 status determined by IHC and/or FISH assay.
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