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
|