Cyclophosphamide and Docetaxel Every 3 Weeks as Neoadjuvant Therapy in Locally Advanced Breast Cancer

Inclusion Criteria:

• Women 18 years of age or older
• Histologically documented adenocarcinoma of the breast, with T2 (T>2.0 cm) N0 or more advanced disease.
• No evidence of metastatic disease.
• Disease must be clinically or radio-graphically measurable or evaluable.
• Incisional or core needle biopsy, yielding sufficient tissue for histologic confirmation of adenocarcinoma, hormone receptor analysis and Her2 testing; and Tiam-1 expression.
• Subjects may have received no prior chemotherapy for breast cancer. Subjects may have received up to 3 months of neoadjuvant hormonal therapy, provided they have been re-staged and are still eligible for this study, and have been off hormonal therapy at least 48 hours.
• Subject must be Her-2 negative.
• Performance status 0-1 by the ECOG scale.
• Baseline laboratory values must be as follows: Absolute granulocyte count: greater than 1400/cells/ml; Platelets: greater than 100,000 cells/ml; Total bilirubin: less than 1.5 mg/dl; Serum ALT: less than 2.5 x institutional upper normal limit; Creatinine: less than 1.6mg/dl; Hemoglobin: greater than 9.0g/dl
• Subjects must be nonpregnant and nonlactating. Subjects of childbearing potential must utilize an effective method of contraception during the study.

Exclusion Criteria:

• Subjects who have received chemotherapy or more than 3 months of neoadjuvant hormone therapy for this cancer.
• Subjects with metastatic disease (disease beyond the breast, axillary nodes and ipsilateral supraclavicular nodes) or inflammatory breast cancer (T4d).
• Subjects with other active cancers, except non-melanoma skin cancers
• Subjects with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
• Dementia or significantly altered mental status that would prohibit comprehension of or giving of informed consent.
• Pregnant or breast-feeding women; sexually active, pre-menopausal women not willing to use adequate methods of birth control.
• Subjects who are Her 2 neu positive are excluded.