Taxol Epirubicin Cyclophosphamide Herceptin Neoadjuvant (TECHNO)

Study Overview
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Brief Summary
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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.

Official Title
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Preoperative Therapy With Epirubicin/Cyclophosphamide Followed by Paclitaxel/Trastuzumab and Postoperative Therapy With Trastuzumab in Patients With HER-2 Over Expressed Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Epirubicin / Cyclophosphamide in combination with Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Epirubicin/Cyclophosphamide in combination with Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab in patients with HER-2 overexpression | Drug: Epirubicin / Cyclophosphamide in combination with Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab<br>* Cycles 1-4 Epirubicin: 90 mg/m2, i.v. day 1 Cyclophosphamide: 600 mg/m2, i.v. day 1 Every 22d Cycles 5-8 Paclitaxel: 175 mg/m2, i.v., 3h-infusion day 1 Trastuzumab: 8 mg/kg i.v. at day 0 of the 5th cycle and thereafter each 6 mg/kg i.v. day 1 in the cycles 6-8 Every 22d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the rate of cardiac (serious) events NYHA III/IV-and pathological complete remission after study therapy. |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess: the rate of breast conserving surgery, the clinical response rates, the histopathological lymph node status after preoperative therapy, the disease-free and overall survival. |  | 36 months | 
| To evaluate the quality of life. |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety and efficacy of experimental treatment