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Status:

COMPLETED

Dose Density FU 75 and FU 90 as Adjuvant Therapy for Early Breast Cancer

Lead Sponsor:

Central European Cooperative Oncology Group

Conditions:

Breast Cancer

Eligibility:

FEMALE

18-75 years

Phase:

PHASE2

Brief Summary

This is an open -label randomized phase II study of dose-dense Fluorouracil/Epirubicin/Cyclophosphamide (FEC) administered with Epirubicin of 75mg/m2 (FEC75) and Epirubicin 90mg/m2 (FEC90) in untreate...

Detailed Description

Arm A: the FEC75 regimen will be given at the following doses: Fluorouracil 500mg/m2 by i.v. bolus or infusion. Epirubicin 75mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolu...

Eligibility Criteria

Inclusion

  • patients with histological diagnosis of invasive breast cancer
  • Patients with early stage I, II,III breast cancer amendable for complete surgical resection.
  • Patients with any nodal status
  • Patients with ER and PR -negative tumors. In case of axillary involvement:any hormonal receptors status.
  • perfomance Status 0-1 on the ECOG Scale
  • patients indicated for adjuvant chemotherapy
  • No previous chemotherapy or radiotherapy
  • Patients have to be randomized within 8 weeks after surgery. Its recommended that patients will start chemotherapy within 1 month after surgical treatment.

Exclusion

  • active infection
  • pregnancy/breast feeding
  • serious concomitant systemic disorders incompatible with the study
  • Second primary malignancy (expect in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
  • Use of any other investigational agent within 4 weeks before enrollment into the study
  • Cocurrent administration of radiation therapy, chemotherapy, hormonal therapy or immunotherapy

Key Trial Info

Start Date :

April 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

September 1 2006

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00286819

Start Date

April 1 2005

End Date

September 1 2006

Last Update

May 16 2012

Active Locations (5)

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Page 1 of 2 (5 locations)

1

AKH, Universitätsklinik für Innere Medizin 1

Vienna, Austria, 1090

2

Onkotherápiás Klinika,

Szeged, Hungary

3

Medical University of Gdansk, Dept. of Oncology and Radiotherapy

Gdansk, Poland, 80-211

4

Nomocnica Sv. Alzbety, Narodny Onkologicky Ustav

Bratislava, Slovakia, 81250