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Taxol Epirubicin Cyclophosphamide Herceptin Neoadjuvant (TECHNO)

Information source: German Breast Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Epirubicin / Cyclophosphamide in combination with Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: German Breast Group

Official(s) and/or principal investigator(s):
Michael Untch, MD, Prof., Principal Investigator, Affiliation: AGO Study Group

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To estimate the rate of cardiac (serious) events NYHA III/IV-and pathological complete remission after study therapy.

Secondary outcome:

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.

To evaluate the quality of life.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Ludwig Maximillian University Munich, Department of Gynecology and Obstetrics, Munich, Bavaria D-81377, Germany
Additional Information

Starting date: January 2002
Last updated: August 15, 2011

Page last updated: August 23, 2015

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