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

NCT ID: NCT00189644

Last Updated: 2005-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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6 FEC 100

Intervention Type PROCEDURE

4 FEC 100 followed by 4 Taxol

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Association Européenne de Recherche en Oncologie

OTHER

Sponsor Role lead

Principal Investigators

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Pascal Piedbois, MD

Role: PRINCIPAL_INVESTIGATOR

Association Europeenne de Recherche en Oncologie

Anne-Chantal Braud, MD

Role: PRINCIPAL_INVESTIGATOR

Association Europeenne de Recherche en Oncologie

Daniel Serin, MD

Role: PRINCIPAL_INVESTIGATOR

Association Europeenne de Recherche en Oncologie

Other Identifiers

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AERO-B2000

Identifier Type: -

Identifier Source: org_study_id