Taxol Epirubicin Cyclophosphamide Herceptin Neoadjuvant (TECHNO)

This study has been completed.
Sponsor:
Collaborator:
AGO Study Group
Information provided by:
German Breast Group
ClinicalTrials.gov Identifier:
NCT00795899
First received: November 20, 2008
Last updated: August 15, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Epirubicin / Cyclophosphamide in combination with Paclitaxel/Trastuzumab, followed by postoperative Trastuzumab
Phase 2

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

Resource links provided by NLM:


Further study details as provided by German Breast Group:

Primary Outcome Measures:
  • To estimate the rate of cardiac (serious) events NYHA III/IV-and pathological complete remission after study therapy. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • To evaluate the quality of life. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Enrollment: 230
Study Start Date: January 2002
Study Completion Date: September 2008
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00795899

Locations
Germany
Ludwig Maximillian University Munich, Department of Gynecology and Obstetrics
Munich, Bavaria, Germany, D-81377
Sponsors and Collaborators
German Breast Group
AGO Study Group
Investigators
Principal Investigator: Michael Untch, MD, Prof. AGO Study Group
  More Information

No publications provided by German Breast Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Udo Pfeil, GBG Forschungs GmbH
ClinicalTrials.gov Identifier: NCT00795899     History of Changes
Other Study ID Numbers: TECHNO
Study First Received: November 20, 2008
Last Updated: August 15, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by German Breast Group:
Safety and efficacy of experimental treatment

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Trastuzumab
Epirubicin
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 29, 2014