Taxol Epirubicin Cyclophosphamide Herceptin Neoadjuvant (TECHNO)

August 15, 2011 updated by: German Breast Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Epirubicin/Cyclophosphamide in combination with Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab in patients with HER-2 overexpression
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To estimate the rate of cardiac (serious) events NYHA III/IV-and pathological complete remission after study therapy.
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome 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.
Time Frame: 36 months
36 months
To evaluate the quality of life.
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Breast Group

Collaborators

AGO Study Group

Investigators

  • Principal Investigator: Michael Untch, MD, Prof., AGO Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (ACTUAL)

December 1, 2005

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

November 20, 2008

First Submitted That Met QC Criteria

November 20, 2008

First Posted (ESTIMATE)

November 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 16, 2011

Last Update Submitted That Met QC Criteria

August 15, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TECHNO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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