Status:
COMPLETED
Taxol Epirubicin Cyclophosphamide Herceptin Neoadjuvant (TECHNO)
Lead Sponsor:
GBG Forschungs GmbH
Collaborating Sponsors:
AGO Study Group
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
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 postop...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00795899
Start Date
January 1 2002
End Date
September 1 2008
Last Update
August 16 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ludwig Maximillian University Munich, Department of Gynecology and Obstetrics
Munich, Bavaria, Germany, D-81377