CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,925 enrolled
Drug / intervention
Fluorouracil +3 moredrug
Likely dose
FAC: fluorouracil, doxorubicin, cyclophosphamide (Arm A); FAC followed by paclitaxel weekly × 8 (Arm B) — specific doses not detailed in recordAI-extracted
Key inclusion· 10
  • ✓Histologically confirmed invasive adenocarcinoma of the breast, T1-T3 stage
  • ✓HER2 negative (IHC 0/+1, or IHC 2+ with negative FISH)
  • ✓Node-negative disease with adequate lymph node assessment (≥10 nodes on lymphadenectomy or sentinel node negative)
  • ✓At least one high-risk criterion: tumor >2 cm, ER/PgR negative, histological grade 2-3, or age <35 years
Key exclusion· 12
  • ✕Prior systemic therapy for breast cancer
  • ✕Prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel)
  • ✕Prior radiotherapy for breast cancer
  • ✕Bilateral invasive breast cancer

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00129389
NCT00129389Phase 3Completed
CompareCT.gov

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

Spanish Breast Cancer Research Group·interventional·Posted Aug 11, 2005·Updated Mar 7, 2023

In Brief

A Phase 3 clinical trial evaluating Fluorouracil, Doxorubicin, and 2 other interventions for Breast Cancer. Completed, enrolled 1,925 participants across 68 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesSpain
CollaboratorsBristol-Myers Squibb

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 11, 2005
Enrollment StartSep 19, 2003
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10.0 yearsPosted 20.9 years ago

Interventions

Fluorouracildrug

Arm A: FAC Arm B: FAC-wP

Doxorubicindrug

Arm A: FAC Arm B: FAC-wP

Cyclophosphamidedrug

Arm A: FAC Arm B: FAC-wP

Paclitaxeldrug

Arm B: FAC-wP