OncRef

Clinical Trial: NCT00129922

Fluorouracil, Epirubicin, and Cyclophosphamide Alone or Followed by Paclitaxel for Early Breast Cancer

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Spanish Breast Cancer Research Group
Information Provided By:Spanish Breast Cancer Research Group
Last Update Posted:2023-03-06

Study Overview

Brief Summary

The efficacy of adjuvant chemotherapy is limited in patients with a high risk of recurrence.

Also, for axillary positive node patients, optimum chemotherapy regimens are still under discussion. Some previous studies suggest that, in the subset of node-positive patients, treatments based on sequential administration of anthracyclines and taxanes are more efficient. Paclitaxel dose-dense (weekly) administration renders an improved therapeutic index (activity/toxicity).

The study is designed to compare 6 courses of FEC scheme (600/90/600), a combination of proven efficacy in node positive breast cancer patients, versus 4 FEC courses followed by 8 weekly paclitaxel administrations (100mg/m2).

The study hypothesis is that 5-year disease-free survival in the control arm will be 60%. The investigators expect to increase this by 8% with the experimental treatment. With an alpha error of 0.05, 80% power, and a post-randomization estimated drop-out rate of 10%, 1250 patients are needed, 625 per arm.

Official Title

Phase III Study to Compare 6 Courses of FEC (Fluorouracil, Epirubicin and Cyclophosphamide) vs. 4 Courses of FEC Followed by 8 Weekly Paclitaxel Administrations, as Adjuvant Treatment for Node Positive Operable BC Patients

Conditions

Breast Cancer

Intervention / Treatment

  • Drug: paclitaxel
  • Drug: Fluorouracil
  • Drug: Epirubicin
  • Drug: Cyclophosphamide

Other Study ID Numbers

  • GEICAM 9906

Start Date (Actual)

1999-11

Primary Completion Date (Actual)

2005-12

Study Completion Date (Actual)

2007-12

Enrollment (Actual)

1289

Study Type

Interventional

Phase

Phase 3