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Taxol Epirubicin Cyclophosphamide Herceptin Neoadjuvant (TECHNO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00795899
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : August 16, 2011
Sponsor:
Collaborator:
AGO Study Group
Information provided by:
German Breast Group

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2002
Actual Primary Completion Date : December 2005
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


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





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

Secondary Outcome Measures :
  1. 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 ]
  2. To evaluate the quality of life. [ Time Frame: 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795899


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Udo Pfeil, GBG Forschungs GmbH
ClinicalTrials.gov Identifier: NCT00795899    
Other Study ID Numbers: TECHNO
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: August 16, 2011
Last Verified: August 2011
Keywords provided by German Breast Group:
Safety and efficacy of experimental treatment
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Trastuzumab
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors