Taxol Epirubicin Cyclophosphamide Herceptin Neoadjuvant (TECHNO)

Inclusion criteria

• Primary carcinoma of the breast, confirmed histologically by core biopsy (at least 3 core biopsy samples)
• Tumor lesion of the breast with a palpable or a imagistic size ≥ 2 cm or inflammatory breast cancer
• Known HER-2 status detected on core biopsy. HER-2 over expression is defined as DAKO HercepTest (3+) or DAKO HercepTest (2+) and FISH (+) (fluorescence-in-situ-hybridisation).
• No distant metastatic disease, confirmed by chest x-ray, abdominal sonography and bone scan.
• Female patients
• Age ≥ 18 and ≤ 65 years
• ECOG < 2/WHO 0-1
• Laboratory requirements GOT and Bilirubin < 1.5x UNL Leukocytes >= 3 G/l Neutrophile > 1 G/l Thrombocytes > 100 G/l Creatinine (Serum) < 2.0 mg/dl.
• Normal cardiac function, confirmed by cardiologist
• No active hepatitis
• Written informed consent for all study procedures
• Patients must be available and compliant for treatment and follow-up

Exclusion criteria

• Multicentricity in various quadrants (contact the study office)
• CNS-metastases
• Secondary malignancy, excluding basalioma of the skin or carcinoma in situ of the cervix that has received curative therapy
• Patients with relevant hemodynamic cardial diseases
• Patients with a left ventricular ejection fraction (LVEF) under the normal limit of the institution, confirmed by echocardiography or MUGA-Scan.
• Uncontrolled, severe comorbidities
• Patients with severe respiratory diseases and severe dyspnea and / or which need supportive oxygen
• Previous anti-HER2-therapy
• Patients receiving immunosuppressant therapy
• Known allergy to medication containing cremophor
• Hb <10 g/dL, Neutrophile <1.5 x109/L, Thrombocytes <100 x109/L.
• Total-Serum-Bilirubin >1.5 x ULN (upper limit of normal) (except in patients with confirmed and documented Gilbert-Lereboullet-syndrome), ALT or AST >2.5 x ULN (>5 x ULN by liver metastases), Alkaline Phosphatase >2.5 x ULN (>4 x ULN by liver or bone metastases), Serumcreatinine > 2 x ULN
• Pregnancy, nursing (a negative pregnancy test must be documented, and safe anticontraceptive measures during pre- and postoperative treatment must be implemented)
• Lack of signed informed consent after informing the patient
• Lack of willingness to keep and disclose personal medical data as part of the study