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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00189644
Other study ID # AERO-B2000
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received September 12, 2005
Last updated September 12, 2005

Study information

Verified date September 2005
Source Association Européenne de Recherche en Oncologie
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
6 FEC 100

4 FEC 100 followed by 4 Taxol


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Association Européenne de Recherche en Oncologie Bristol-Myers Squibb
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