Breast Cancer
Conditions
Keywords
Safety and efficacy of experimental treatment
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.
Interventions
DRUGEpirubicin / Cyclophosphamide in combination with Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab
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
Sponsors
AGO Study Group
GBG Forschungs GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the rate of cardiac (serious) events NYHA III/IV-and pathological complete remission after study therapy. | 36 months |
Secondary
| Measure | 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 |
Countries
Germany
Outcome results
None listed