This Trial is a Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas (IELSG33)

Previously untreated patients with localized DLBCL of the breast.

Inclusion Criteria:

• 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 study.
• 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 x ULN.
  • 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.

Exclusion Criteria:

• 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 contraception.
• active infection requiring parental antibiotics.
• known HIV infection