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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
January 2010
NCT00688740Uploaded 04-15-2015
Available for Download
PDS UID: Breast_SanofiU_1997_120
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.
Provider Information
Provider Data Description Primary Objective: To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide (TAC) to 5-fluorouracil in combination with doxorubicin and cyclophosphamide (FAC) in operable breast cancer patients with positive axillary lymph nodes. Secondary Objectives: To compare overall survival between the 2 above mentioned arms. To compare toxicity and quality of life between the 2 above mentioned arms. To evaluate pathologic and molecular markers for predicting efficacy. An independent socio-economic study will be conducted in parallel with the clinical study.
SponsorSanofi US Services Inc.
Data ProviderSanofi
Partial set or SubsetOriginal Data
Patients in dataset1491
# of Patients Control746
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/m0vr-xp79
CDISC StandardADS
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe 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.
ConditionsBreast Cancer
Intervention TypeDrug: Docetaxel
Drug: 5-fluorouracil
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug(s)Drug: Docetaxel
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: 5-fluorouracil
Total Enrolled1491
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionTAC (Docetaxel) - Experimental
FAC (5-fluorouracil) - Active Comparator
Secondary IDXRP6976D-316
PubMed (PMID)15930421
23246022
Collaborator(s)Cancer International Research Group (CIRG)
Region(s)United States
Argentina
Austria
Brazil
Canada
Czech Republic
Egypt
France
Germany
Greece
Hungary
Israel
Poland
Portugal
Slovakia
South Africa
Spain
Sweden
United Kingdom
Uruguay
Age Range18 Years to 70 Years (Adult, Older Adult)
Files:
PROTOCOLsanofi_XRP6976D_TAX316 Amended_Protocol 6_Redacted.pdf
CRFsanofi_XRP6976_TAX316_crf_Redacted.pdf
DATA DICTIONARYsanofi_XRP6976_TAX316_data_definition.doc
DATA (COMPARATOR ARM)sanofi_XRP6976_TAX316.zip
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