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Trial record 34 of 100 for:    FEC

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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
German Breast Group
Information provided by (Responsible Party):
Christoph Thomssen, Martin-Luther-Universität Halle-Wittenberg

Tracking Information
First Submitted Date  ICMJE October 15, 2010
First Posted Date  ICMJE October 18, 2010
Last Update Posted Date June 26, 2017
Study Start Date  ICMJE January 2002
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2010)
Disease-Free Survival [ Time Frame: after 10 years follow up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01222052 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2010)
Overall Survival [ Time Frame: after 10 years follow up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 6xFU/Epirubicin/Cyclophosphamide (FEC) Compared to 3xFEC-3xDocetaxel in High-risk Node-negative Breast Cancer Patients
Official Title  ICMJE 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
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.
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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE 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

Study Arms  ICMJE
  • Experimental: Arm A Taxane-containing
    3 courses FEC q3weeks followed by 3 courses Docetaxel q3weeks
    Intervention: Drug: 5-Fluorouracil, Epirubicin, Cyclophosphamide, Docetaxel
  • Active Comparator: Arm B standard anthracyclin
    6 courses of FEC q3weeks
    Intervention: Drug: 5-Fluorouracil, Epirubicin, Cyclophosphamide, Docetaxel
  • No Intervention: Observation
Publications * Kantelhardt EJ, Vetter M, Schmidt M, Veyret C, Augustin D, Hanf V, Meisner C, Paepke D, Schmitt M, Sweep F, von Minckwitz G, Martin PM, Jaenicke F, Thomssen C, Harbeck N. Prospective evaluation of prognostic factors uPA/PAI-1 in node-negative breast cancer: phase III NNBC3-Europe trial (AGO, GBG, EORTC-PBG) comparing 6×FEC versus 3×FEC/3×Docetaxel. BMC Cancer. 2011 Apr 16;11:140. doi: 10.1186/1471-2407-11-140.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 15, 2010)
4150
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2019
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01222052
Other Study ID Numbers  ICMJE GBG 42
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christoph Thomssen, Martin-Luther-Universität Halle-Wittenberg
Study Sponsor  ICMJE Martin-Luther-Universität Halle-Wittenberg
Collaborators  ICMJE German Breast Group
Investigators  ICMJE
Principal Investigator: Christoph Thomssen, MD Dpt. Gynecology University Halle Germany
Principal Investigator: Nadia Harbeck, MD Breast Center University Cologne
PRS Account Martin-Luther-Universität Halle-Wittenberg
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP