OncRef

Clinical Trial: NCT00129389

FAC Versus FAC Plus Weekly Paclitaxel as Adjuvant Treatment of Node Negative High Risk Breast Cancer Patients

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Spanish Breast Cancer Research Group
Information Provided By:Spanish Breast Cancer Research Group
Last Update Posted:2023-03-07

Study Overview

Brief Summary

This is a prospective, open-label, randomized, phase III trial. Patients will be stratified after breast surgery, as per investigational site; menopausal status; node negative diagnosis, as per sentinel-node technique versus lymphadenectomy; hormone receptor status (positive versus negative).

Official Title

Multicenter Randomized Phase III Trial to Compare 6 FAC Cycles vs 4 FAC Cycles Followed by 8 Weekly Paclitaxel Administrations, as Adjuvant Treatment for Node Negative Operable Breast Cancer Patients

Conditions

Breast Cancer

Intervention / Treatment

  • Drug: Fluorouracil
  • Drug: Doxorubicin
  • Drug: Cyclophosphamide
  • Drug: Paclitaxel

Other Study ID Numbers

  • GEICAM 2003-02
  • 2005-003109-10
  • 2005

Start Date (Actual)

2003-09-19

Primary Completion Date (Actual)

2013-10-01

Study Completion Date (Actual)

2013-10-01

Enrollment (Actual)

1925

Study Type

Interventional

Phase

Phase 3