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6xFU/Epirubicin/Cyclophosphamide (FEC) Compared to 3xFEC-3xDocetaxel in High-risk Node-negative Breast Cancer Patients (NNBC3-Europe)

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. Identifier: NCT01222052
Recruitment Status : Unknown
Verified June 2017 by Christoph Thomssen, Martin-Luther-Universität Halle-Wittenberg.
Recruitment status was:  Active, not recruiting
First Posted : October 18, 2010
Last Update Posted : June 26, 2017
German Breast Group
Information provided by (Responsible Party):
Christoph Thomssen, Martin-Luther-Universität Halle-Wittenberg

Brief Summary:
In low-risk node-negative breast cancer patients adjuvant chemotherapy should be spared. The identification of this subgroup can be based either on clinical and pathological or on tumour-biological criteria. Due to their high prognostic impact, the tumour-biological invasion markers uPA/PAI-1 (urokinase-type plasminogen activator and its inhibitor PAI-1) are potential candidates to effectively assess the risk of relapse in node-negative breast cancer. This study is aimed to compare the risk assessment by the traditional clinico-pathological factors and by tumour-biological factors. The second study question refers to the comparison between an adjuvant combination treatment with FE100C*6 and a sequential treatment with FE100C*3 and Docetaxel*3.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: 5-Fluorouracil, Epirubicin, Cyclophosphamide, Docetaxel Phase 3

Detailed Description:
  1. To compare FEC*6 with FEC*3 followed by DOC*3 with regard to:

    • the primary endpoint of the study: Disease-Free Survival (DFS)
    • the secondary endpoints: Overall Survival (OS), compliance, and toxicity of chemotherapy in each patient group
  2. To compare patients with low risk according to clinico-pathological versus those according to biological risk criteria with regard to:

    • the proportion of low risk versus high risk patients
    • DFS
    • OS (secondary endpoint)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Multicenter Study Comparing 6xFEC With 3xFEC-3xDoc in High-risk Node-negative Patients With Operable Breast Cancer: Comparison of Efficacy and Evaluation of Clinico-pathological and Biochemical Markers as Risk Selection Criteria
Study Start Date : January 2002
Actual Primary Completion Date : February 2009
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm A Taxane-containing
3 courses FEC q3weeks followed by 3 courses Docetaxel q3weeks
Drug: 5-Fluorouracil, Epirubicin, Cyclophosphamide, Docetaxel

Arm A 5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 q3weeks followed by Docetaxel 100 mg/m² q3weeks

Arm B 5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 q6weeks

Active Comparator: Arm B standard anthracyclin
6 courses of FEC q3weeks
Drug: 5-Fluorouracil, Epirubicin, Cyclophosphamide, Docetaxel

Arm A 5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 q3weeks followed by Docetaxel 100 mg/m² q3weeks

Arm B 5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 q6weeks

No Intervention: Observation

Primary Outcome Measures :
  1. Disease-Free Survival [ Time Frame: after 10 years follow up ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: after 10 years follow up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histological proven primary breast cancer
  • Tumour size >0.5 cm and <5 cm (pT1b-pT2, pN0, M0)
  • Axillary lymph nodes tumour free (node-negative disease)
  • Adequate surgical procedure: R0-resection and axillary dissection with more than 10 lymph nodes examined or adequate sentinel procedure in a qualified centre
  • Frozen tumour tissue available (for analysis of biological markers and microarrays, centres with biological risk assessment only). The material has to be stored in liquid nitrogen immediately after excision.
  • Paraffin blocks or (at least) pathology slides of primary tumour (stained and unstained) and axillary nodes (stained) available for central review.
  • HER-2/neu determination by immunohistochemistry. Patients will be stratified to be HER-2/neu-negative or HER-2/neu-positive (HER-2/neu Score 3+, or HER-2/neu Score 2+ and FISH positive).
  • No distant metastasis
  • Age >18 years, <70 years
  • Performance status ECOG <2 (WHO Performance Status 0-1)
  • Adequate cardiac function (echocardiographically measured left ventricular ejection fraction (LVEF) or shortening fraction (SF) within the normal limits, i.e. ≥55%)
  • Adequate bone function (neutrophil count >1.5 x109 /l and platelet count >100 x109 /l)
  • Adequate renal function (serum creatinine <120 µmol/l or 1.35 mg/dl) and hepatic function (serum bilirubin <1 x UNL, ASAT or ALAT (SGOT or SGPT) <2,5 x UNL)
  • Before patient registration/randomization, written informed consent must be obtained according to ICH/EU GCP, and national/local regulations

Exclusion Criteria:

  • Chemotherapy contraindicated
  • Inflammatory breast cancer, tumour infiltrated axillary lymph nodes including the sentinel node.
  • Other concomitant pathology compromising survival (at entry), or preventing the administration of chemotherapy with either FEC or Docetaxel
  • Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study
  • Estimated life-expectancy <10 years (irrespective of breast cancer diagnosis)
  • Patient not accessible for treatment and follow up
  • Endocrine treatment not according to the latest standard recommendations of the AGO Kommission "Mamma"
  • Pregnancy, lactation (sufficient non-hormonal contraception in fertile women required)
  • Surgery more than six weeks ago at the start of chemotherapy
  • Pre-existing polyneuropathy
  • Previous or concomitant other malignancy (including contralateral breast cancer) except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix
  • Prior chemotherapy or radiotherapy or endocrine therapy

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 identifier (NCT number): NCT01222052

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GBG Forschungs GmbH
Neu-Isenburg, Germany, 63263
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
German Breast Group
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Principal Investigator: Christoph Thomssen, MD Dpt. Gynecology University Halle Germany
Principal Investigator: Nadia Harbeck, MD Breast Center University Cologne

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Christoph Thomssen, Prof. Dr. Christoph Thomssen, Martin-Luther-Universität Halle-Wittenberg Identifier: NCT01222052     History of Changes
Obsolete Identifiers: NCT02681003
Other Study ID Numbers: GBG 42
First Posted: October 18, 2010    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017

Keywords provided by Christoph Thomssen, Martin-Luther-Universität Halle-Wittenberg:
high risk breast cancer
low risk breast cancer
urokinase-type plasminogen activator
plasminogen activator inhibitor-type

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antimetabolites, Antineoplastic
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Fibrinolytic Agents
Fibrin Modulating Agents