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Constantine V. Godellas
Patients (male or female) must have an intact primary (not recurrent) invasive carcinoma of the breast. Biopsy confirmation of the primary tumor should be by needle biopsy (preferred); incisional surgical biopsy is allowed as long as there is residual palpable or imageable tumor in the breast. Patients with synchronous contralateral breast cancer are excluded. Patients should have at least one site of distant metastatic disease. If only a single metastatic lesion is present, biopsy is mandatory. Radiology reports documenting status of disease prior to initiation of systemic therapy must be available. Scans must have been completed within four weeks prior to start of systemic therapy. If patient has only one site of metastatic disease, this must be proven by biopsy and the pathology report confirming the diagnosis of primary breast cancer, as well as the metastatic site, must be available.
Patients may have had prior non-invasive (DCIS) cancer if there has been no recurrence. Patients with a history of other primary cancers are eligible if the pathology report confirming the diagnosis of primary breast cancer is available, and the other primary cancer was curatively treated with a five-year, disease-free interval. Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception. Patients with CNS metastases are eligible (as long as projected survival is > six months).
The purpose of this study is to compare the good and/or bad effects of a new approach that includes surgery plus radiation for the tumor in your breast to the standard approach of continued treatment with medication.