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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
October 2008
NCT00312208Uploaded 03-06-2015
Available for Download
PDS UID: Breast_SanofiU_2000_118
A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide Versus Doxorubicin and Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment of Operable Breast Cancer HER2neu Negative Patients With Positive Axillary Lymph Nodes
Provider Information
Provider Data DescriptionObjectives: Primary objective: To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide (TAC) to doxorubicin and cyclophosphamide followed by docetaxel (AC->T) in operable adjuvant breast cancer HER2 negative patients with positive axillary lymph nodes. Secondary objectives: 1)To compare overall survival between the 2 above mentioned arms. 2) To compare toxicity and quality of life between the 2 above-mentioned arms. 3) To evaluate pathologic and molecular markers for predicting efficacy. 4) An independent socioeconomic study was planned in parallel with the clinical study but it was not analyzed
SponsorSanofi US Services Inc.
Data ProviderSanofi
Partial set or SubsetOriginal Data
Patients in dataset3298
# of Patients Control1650
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/wapf-wx46
CDISC StandardNon standard raw data
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryPrimary objective : To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide followed by docetaxel in operable adjuvant breast cancer HER2neu negative patients with positive axillary lymph nodes. Secondary objectives : To compare toxicity and quality of life between the 2 above-mentioned arms. To evaluate pathologic and molecular markers for predicting efficacy.
ConditionsBreast Cancer
Intervention TypeDrug: docetaxel, doxorubicin, cyclophosphamide
Drug: Docetaxel,doxorubicin, cyclophosphamide
Drug(s)Drug: Docetaxel,doxorubicin, cyclophosphamide
Drug: docetaxel, doxorubicin, cyclophosphamide
Total Enrolled3299
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms Intervention1 - Experimental
2 - Experimental
Secondary IDBCIRG 005
PubMed (PMID)27573653
26940688
Collaborator(s)Cancer International Research Group (CIRG)
Region(s)United States
Argentina
Australia
Belgium
Bosnia and Herzegovina
Brazil
Bulgaria
Canada
China
Colombia
Croatia
Cyprus
Czech Republic
Egypt
Estonia
France
Germany
Greece
Hong Kong
Hungary
Ireland
Israel
Korea, Republic of
Lebanon
Mexico
New Zealand
Poland
Portugal
Romania
Russian Federation
Saudi Arabia
Slovenia
South Africa
Spain
Taiwan
Uruguay
Venezuela
Age Range18 Years to 70 Years (Adult, Older Adult)
Files:
PROTOCOLsanofi_xrp6976_tax_gma_301_study_protocol.pdf
CRFsanofi_xrp6976_tax_gma_301_CRF.pdf
DATA DICTIONARYsanofi_XRP6976_TAX_GMA_301_data_descriptors.xls
DATA (COMPARATOR ARM)XRP6976_TAX_GMA_Data.zip
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