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6 FEC 100 Vs 4 FEC 100 Followed by 4 Taxol in N+ Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
6 FEC 100
4 FEC 100 followed by 4 Taxol
Sponsored by
Association Européenne de Recherche en Oncologie
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Histologically proven cancer of the breast, Mastectomy or complete tumorectomy, Histologically proven homolateral, axillary lymph node involvement (at least 1 N+) Period between surgery (second operation in case of primarily incomplete resection) and the start of chemotherapy < 2 months, Biological criteria (before the first FEC cycle): Neutrophils >1.5 109 /L Platelets >100 109/L Hemoglobin >10 g/dl Creatininemia <120 mmol/1 Bilirubinemia <1.5 Upper normal value Female patients over 18 years old Written and signed informed consent Performance Status less than or equal to 2 (WHO scale, see Annex IV) Exclusion Criteria: Prior chemotherapy or radiotherapy, including neo-adjuvant treatment for cancer of the breast, Bilateral breast cancer or history of contralateral breast cancer Cardiac history: cardiac insufficiency (LVEF <50%) or coronary decompensation Pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential) Inflammatory breast cancer Distant metastasis or supraclavicular adenopathy Benign pathology or history of malignant pathology accompanied by a life expectancy of less than two years Contra-indication to Anthracyclines, Cyclophosphamide, 5FU or Taxol Psychiatric pathology Patient participating in another trial

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    September 12, 2005
    Sponsor
    Association Européenne de Recherche en Oncologie
    Collaborators
    Bristol-Myers Squibb
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00189644
    Brief Title
    6 FEC 100 Vs 4 FEC 100 Followed by 4 Taxol in N+ Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2005
    Overall Recruitment Status
    Unknown status
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Association Européenne de Recherche en Oncologie
    Collaborators
    Bristol-Myers Squibb

    4. Oversight

    5. Study Description

    Brief Summary
    The main objective of this randomized trial is to compare 6 FEC100 to 4 FEC100 + 4 Taxol in patients with resected node positive breast cancer. Main endpoint is disease free survival. Secondary endpoints are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 840 patients have been included in the trial.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    6 FEC 100
    Intervention Type
    Procedure
    Intervention Name(s)
    4 FEC 100 followed by 4 Taxol

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologically proven cancer of the breast, Mastectomy or complete tumorectomy, Histologically proven homolateral, axillary lymph node involvement (at least 1 N+) Period between surgery (second operation in case of primarily incomplete resection) and the start of chemotherapy < 2 months, Biological criteria (before the first FEC cycle): Neutrophils >1.5 109 /L Platelets >100 109/L Hemoglobin >10 g/dl Creatininemia <120 mmol/1 Bilirubinemia <1.5 Upper normal value Female patients over 18 years old Written and signed informed consent Performance Status less than or equal to 2 (WHO scale, see Annex IV) Exclusion Criteria: Prior chemotherapy or radiotherapy, including neo-adjuvant treatment for cancer of the breast, Bilateral breast cancer or history of contralateral breast cancer Cardiac history: cardiac insufficiency (LVEF <50%) or coronary decompensation Pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential) Inflammatory breast cancer Distant metastasis or supraclavicular adenopathy Benign pathology or history of malignant pathology accompanied by a life expectancy of less than two years Contra-indication to Anthracyclines, Cyclophosphamide, 5FU or Taxol Psychiatric pathology Patient participating in another trial
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pascal Piedbois, MD
    Organizational Affiliation
    Association Europeenne de Recherche en Oncologie
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Anne-Chantal Braud, MD
    Organizational Affiliation
    Association Europeenne de Recherche en Oncologie
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Daniel Serin, MD
    Organizational Affiliation
    Association Europeenne de Recherche en Oncologie
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    6 FEC 100 Vs 4 FEC 100 Followed by 4 Taxol in N+ Breast Cancer

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