Safety Study Of Chemotherapy Combined With Dendritic Cell Vaccine to Treat Breast Cancer

• Inclusion Criteria:

A patient will be considered for enrollment in this study if all of the following criteria are met:

• Female patients ≥18 years of age.
• Have either:
• locally advanced TNBC defined as invasive ductal cancer; ER- tumors with 1500/mm3
• Platelet count ≥100,000/mm3
• Hemoglobin >9 g/dL (in the absence of red blood cell transfusion)
• Adequate liver function, defined by:
• AST and ALT ≤2.5 x the upper limit of normal (ULN)
• Total bilirubin ≤1.5 x ULN
• Adequate renal function, defined by:

a. Serum creatinine ≤1.5 x ULN or calculated creatinine clearance of ≥60 ml/min

• Patients with previous history of invasive cancers (including breast cancer) are eligible if definitive treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease.
• Eligible for treatment with paclitaxel, doxorubicin, cyclophosphamide and carboplatine.
• Patient must be accessible for treatment and follow-up.
• Patients must be willing to undergo research biopsies to obtain breast cancer tissue for whole exome sequencing and evaluation of tumor immune microenvironment.
• All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry.
• Exclusion Criteria:

A patient will be ineligible for inclusion in this study any of the following criteria are met:

• Evidence of metastatic disease on bone scan and CT scan of chest/abdomen (or PET CT scan). Patients with intrathoracic metastatic adenopathy are eligible.
• Active infection or unexplained fever >38.5°C during screening.
• Active infections including viral hepatitis and HIV.
• Active asthma or other condition requiring steroid therapy.
• Autoimmune disease including lupus erythematosus or rheumatoid arthritis. Topical or inhaled corticosteroids are allowed.
• Patients who are currently receiving or who have received previous systemic therapy for breast cancer (eg, chemotherapy, antibody therapy, targeted agents).The use of an LHRH agonist during chemotherapy in premenopausal women who wish to preserve ovarian function is allowed, but is not required.
• Women who are pregnant or lactating. All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.
• Have a NYHA Class III or IV CHF or LVEF 1.5 x ULN
• liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C).
• History of any other disease, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug, or that might affect interpretation of the results of this study, or render the patient at high risk for treatment complications.
• Any other investigational or anti-cancer treatments while participating in this study.
• Any other cancer