Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Docetaxel as Neoadjuvant Treatment of Breast Cancer Patients

Inclusion Criteria

• •Written informed consent.
• •Patients with breast cancer stages II and IIIA, with histological diagnoses as per true-cut or open biopsy.
• •Negative extension study, including bilateral mammography, thoracic x-ray, computed tomography (CT)-scan or abdominal echography and bone scintigraphy.
• •Analysis of hormone receptor status in primary tumour. It is highly recommended to obtain a tumour tissue sample before start of treatment, and after definitive surgery. These samples will be analysed centrally by Spanish Breast Cancer Research Group (GEICAM).
• •Age \>= 18 and \<= 70 years old.
• •Performance status as per Karnofsky index \>= 80.
• •Minimum life expectancy of 6 months.
• •Electrocardiogram (EKG) 12 weeks before registration to the study. If abnormalities are suspected, cardiac function must be assessed by left ventricular ejection fraction (LVEF).
• •Haematology: neutrophils \>= 2.0 x10\^9/l; platelets \>= 100 x10\^9/l; hemoglobin \>=10 g/dl.
• •Hepatic function: total bilirubin \<= 1 x upper normal limit (UNL); Aspartate aminotransferase (AST) (SGOT) and and Alanine aminotransferase (ALT) (SGPT) \<= 2.5 x UNL; alkaline phosphatase \<= 5 x UNL.
• •Renal function: creatinine \<= 1.5 x UNL; creatinine clearance \>= 60 ml/min.
• •Patients able to comply with study requirements.
• •Negative pregnancy test.
• •Adequate contraceptive method during the study and up to 3 months after definitive surgery.