At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,491 enrolled
Drug / intervention
Docetaxel +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide (TAC) Versus 5-fluorouracil in Combination With Doxorubicin and Cyclophosphamide (FAC) as Adjuvant Treatment of Operable Breast Cancer Patients With Positive Axillary Lymph Nodes.
In Brief
A Phase 3 clinical trial evaluating Docetaxel, 5-fluorouracil, and 2 other interventions for Breast Cancer. Completed, enrolled 1,491 participants across 20 sites in 20 countries.
Detailed Summary
The purpose of this study was to compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to 5-fluorouracil in combination with doxorubicin and cyclophosphamide in operable breast cancer patients with positive axillary lymph nodes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesArgentina, Austria, Brazil, Canada, Czechia, Egypt, France, Germany, Greece, Hungary, Israel, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, United Kingdom, United States, Uruguay
CollaboratorsCancer International Research Group (CIRG)
Timeline
Phase 3CompletedFinished
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 1997
First PostedJun 2008
Primary CompletionJan 2010
TodayJul 2026
First PostedJun 3, 2008
Enrollment StartJun 1, 1997
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 12.6 yearsPosted 18.1 years ago
Interventions
Docetaxeldrug
intravenous
5-fluorouracildrug
intravenous
Doxorubicindrug
intravenous
Cyclophosphamidedrug
intravenous