A Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas Treated With R-CHOP With or Without Radiotherapy
- Previously untreated patients with DLBCL of the breast.
- Patients must have CD20 positive tumors.
- Stage IE or IIE.
- Must have at least one objective measurable or evaluable disease. Baseline
measurements and evaluations must be obtained within 4 weeks of registration to the
- Patients must have an ECOG performance status 0-2.
- Patients must have adequate organ function as evidenced by the following laboratory
studies ( within 2 weeks prior to registration):
- Creatinine Clearance > 50 ml/min
- Total bilirubin < 2.0 mg/dl and AST < 2 x upper limit of normal. If documented
hepatic involvement with lymphoma, total bilirubin can be < 3 x ULN, and AST < 5
- Absolute neutrophil count > 1500/mm3 and platelet count > 100,000/mm3. If
documented bone marrow involvement with lymphoma, absolute neutrophil count >
500/mm3 and platelet count > 50,000/mm3.
- Patients must be age > 18 years.
- Patients must have a normal left ventricular ejection fraction to be eligible.
- historical or radiographic evidence of CNS metastasis including previously treated,
resected or asymptomatic brain lesions or leptomeningeal involvement.
- pregnant or breast feeding patients. Women of childbearing potential and sexually
active males are strongly advised to use an accepted and effective method of
- active infection requiring parental antibiotics.
- known HIV infection