Taxol Epirubicin Cyclophosphamide Herceptin Neoadjuvant (TECHNO)
Taxol Epirubicin Cyclophosphamide Herceptin Neoadjuvant (TECHNO)
The present clinical trial will investigate the safety and efficacy of a sequential
 preoperative therapy with Epirubicin/Cyclophosphamide in combination with
 Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab in patients with HER-2
 overexpression primary breast cancer.
Inclusion Criteria:

 1. Primary carcinoma of the breast, confirmed histologically by core biopsy (at least 3
 core biopsy samples)

 2. Tumor lesion of the breast with a palpable or a imagistic size ≥ 2 cm or inflammatory
 breast cancer

 3. 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).

 4. No distant metastatic disease, confirmed by chest x-ray, abdominal sonography and bone
 scan.

 5. Female patients

 6. Age ≥ 18 and ≤ 65 years

 7. ECOG < 2/WHO 0-1

 8. 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.

 9. Normal cardiac function, confirmed by cardiologist

 10. No active hepatitis

 11. Written informed consent for all study procedures

 12. Patients must be available and compliant for treatment and follow-up

 Exclusion Criteria:

 1. Multicentricity in various quadrants (contact the study office)

 2. CNS-metastases

 3. Secondary malignancy, excluding basalioma of the skin or carcinoma in situ of the
 cervix that has received curative therapy

 4. Patients with relevant hemodynamic cardial diseases

 5. Patients with a left ventricular ejection fraction (LVEF) under the normal limit of
 the institution, confirmed by echocardiography or MUGA-Scan.

 6. Uncontrolled, severe comorbidities

 7. Patients with severe respiratory diseases and severe dyspnea and / or which need
 supportive oxygen

 8. Previous anti-HER2-therapy

 9. Patients receiving immunosuppressant therapy

 10. Known allergy to medication containing cremophor

 11. Hb <10 g/dL, Neutrophile <1.5 x109/L, Thrombocytes <100 x109/L.

 12. 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

 13. Pregnancy, nursing (a negative pregnancy test must be documented, and safe
 anticontraceptive measures during pre- and postoperative treatment must be
 implemented)

 14. Lack of signed informed consent after informing the patient

 15. Lack of willingness to keep and disclose personal medical data as part of the study