Taxotere and Adriamycin/Cytoxan (AC) Validation in Breast Cancer Patients

Inclusion Criteria

• All patients must be female.
• Signed informed consent.
• Primary breast cancers must be of clinical and/or radiologic size >3 cm, and deemed surgically operable.
• Negative serum pregnancy test (bHCG) within 7 days of starting study, if of child-bearing potential.
• Adequate bone marrow function:
• Hematocrit of greater than 30%,
• total neutrophil count must be >1.5 x 10^9/L and
• platelets of > 100 x 10^9/L prior to the start of any cycle.
• Renal function tests:
• creatinine within 1.5 times of the institution's upper limit of normal (ULN).
• Liver function tests:
• Total serum bilirubin within ULN, and
• liver transaminases within 2.5 times ULN, and
• alkaline phosphatase within 5 times ULN.
• Electrocardiogram showing no acute ischemic changes.
• Performance status (World Health Organization [WHO] scale) 18 years.
• Patients older than 70 years of age should have left ventricular ejection fraction within ULN by multigated acquisition scan (MUGA) or 2D echocardiogram.

Exclusion Criteria

• Patients with metastatic breast cancer.
• Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
• Women who are lactating or breastfeeding.
• Severe underlying chronic illness or disease.
• Peripheral neuropathy - grade 2 or greater.
• Patients on other investigational drugs while on study will be excluded.
• Severe or uncontrolled hypertension, history of congestive heart failure, acute myocardial infarction, or severe coronary arterial disease.
• Prior taxane or anthracycline chemotherapy for malignancy.
• Patients with a history of severe hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80.
• No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.