Taxol Epirubicin Cyclophosphamide Herceptin Neoadjuvant (TECHNO)

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795899
• Other study ID #: TECHNO
• Status: Completed
• Phase: Phase 2
• First received: November 20, 2008
• Last updated: August 15, 2011
• Start date: January 2002
• Est. completion date: September 2008

Study information

• Verified date: August 2011
• Source: German Breast Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: September 2008
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Epirubicin / 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

Locations

Country	Name	City	State
Germany	Ludwig Maximillian University Munich, Department of Gynecology and Obstetrics	Munich	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
German Breast Group	AGO Study Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the rate of cardiac (serious) events NYHA III/IV-and pathological complete remission after study therapy.		36 months	Yes
Secondary	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	Yes
Secondary	To evaluate the quality of life.		36 months	Yes