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


Phase 2
18 Years
65 Years
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

36 months

Safety Issue:

Yes

Principal Investigator

Michael Untch, MD, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

AGO Study Group

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

TECHNO

NCT ID:

NCT00795899

Start Date:

January 2002

Completion Date:

September 2008

Related Keywords:

  • Breast Cancer
  • Safety and efficacy of experimental treatment
  • Breast Neoplasms

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