Clinical Research Directory

INCLUSION CRITERIA: The following criteria are necessary for study participation: 1. Histologically or cytologically confirmed breast carcinoma, stage I-IV, which has not been treated with any first-line therapy and will be treated with neoadjuvant chemotherapy or neoadjuvant combined chemo-radiotherapy. 2. Measurable disease by ultrasound, or MRI performed within 28 days prior to treatment. 3. Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1. 4. Life expectancy of at least 6 months. 5. Adequate bone marrow, liver and renal function as assessed by the following laboratory. Requirements to be conducted within 7 days prior to dosing: (i) hemoglobin \>90 mg/dL (ii) leukocytes \>3,000/mL (iii) absolute neutrophil count \>1,500/mL (iv) platelets \>100,000/mL (v) total bilirubin within normal institutional limits (vi) AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal (vii) creatinine within normal institutional limits or creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional upper limit of normal 6. Patients should have the ability to understand and the willingness to sign a written informed consent document. Signed informed consent must be obtained prior to any study specific procedures. EXCLUSION CRITERIA The following conditions will exclude women from participation: 1. Chemotherapy, radiotherapy, or major surgery within 4 weeks prior to registering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration. 2. Receiving any other investigational agents. 3. Known brain metastases. 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition.