Taxol Epirubicin Cyclophosphamide Herceptin Neoadjuvant (TECHNO)
Phase 2
Completed
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00795899
- Lead Sponsor
- German Breast Group
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 230
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Epirubicin / Cyclophosphamide in combination with Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab Epirubicin/Cyclophosphamide in combination with Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab in patients with HER-2 overexpression
- Primary Outcome Measures
Name Time Method To estimate the rate of cardiac (serious) events NYHA III/IV-and pathological complete remission after study therapy. 36 months
- Secondary Outcome Measures
Name Time Method To evaluate the quality of life. 36 months 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
Trial Locations
- Locations (1)
Ludwig Maximillian University Munich, Department of Gynecology and Obstetrics
🇩🇪Munich, Bavaria, Germany