Neo-Adjuvant Study in Triple Negative Breast Cancer Patients

Inclusion Criteria:

• Patients with histologic confirmation of invasive breast carcinoma.
• Patients must have intact primary tumor.
• Patients greater than or equal to 18 years.
• Patients should have T1N1-3M0 or T2-4 N0-3M0.
• Patients with bilateral breast cancer are eligible.
• Patients with second primary breast cancers are eligible.
• Patients should have a Karnofsky performance scale of greater than or equal to 70%.
• Patients must have clinically measurable disease to be treated in the neoadjuvantsetting.
• Patients should have adequate bone marrow function, as defined by peripheralgranulocyte count of greater than or equal to 1500/mm^3, and platelet count greaterthan or equal to 100000mm^3.
• Patients must have adequate liver function with a bilirubin within normal laboratoryvalues. Alkaline phosphatase and transaminases (ALT and AST) may be up to 1.5 x upperlimit of normal (ULN) of the institution.
• Patients should have adequate renal function with creatinine levels within normalrange.
• Patients should have a normal left ventricular ejection fraction (LVEF) of greaterthan or equal to 50%.
• Negative serum or urine pregnancy test for a woman of childbearing potential (WOCBP).
• WOCBP must use a reliable and appropriate contraceptive method during the study andsix months after chemotherapy is completed. WOCBP are women who are not menopausal for 12 months or had no previous surgical sterilization.
• Patients must agree to have study biopsies.
• Patients must sign an informed consent indicating that they are aware of theinvestigational nature of the study, in keeping with institutional policy.

Exclusion Criteria:

• Patients with a history of other invasive malignancies diagnosed and treated withinthe previous 5 years, except non-melanoma skin cancer and non-invasive cervicalcancer.
• Her2Neu, ER and PR positive patients should be excluded.
• Patients with Inflammatory breast cancer (IBC) are excluded.
• Patients with an organ allograft or other history of immune compromise.
• Prior treatment with any investigational drug within the preceding 4 weeks.
• Chronic treatment with systemic steroids or another immunosuppressive agent.
• A Known history of HIV seropositivity.
• Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin defined as 1 mg a day).
• Other concurrent and/or uncontrolled medical disease which could compromiseparticipation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension,severe infection, severe malnutrition, unstable angina, or congestive heart failure -New York Heart Association Class III or IV, ventricular arrhythmias, active ischemicheart disease, myocardial infarction within six months, chronic liver or renaldisease, active upper GI tract ulceration).
• Patients with a pre-existing peripheral neuropathy.