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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
September 2011
NCT00174655Uploaded 04-15-2015
Available for Download
PDS UID: Breast_SanofiU_1998_127
An Intergroup Phase III Trial to Evaluate the Activity of Docetaxel, Given Either Sequentially or in Combination With Doxorubicin, Followed by CMF, in Comparison to Doxorubicin Alone or in Combination With Cyclophosphamide, Followed by CMF, in the Adjuvant Treatment of Node-positive Breast Cancer Patients.
Provider Information
Provider Data DescriptionPrimary objectives: 1) To compare disease-free survival of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin followed by CMF in operable breast cancer patients with positive axillary lymph nodes. 2)To compare disease-free survival of an adjuvant treatment with docetaxel in combination with doxorubicin followed by CMF to doxorubicin in combination with cyclophosphamide followed by CMF in operable breast cancer patients with positive axillary lymph nodes. Secondary objectives: 1)To compare disease-free survival of an adjuvant treatment with docetaxel given either sequentially or in combination with doxorubicin and followed by CMF to doxorubicin alone or in combination with cyclophosphamide and followed by CMF in operable breast cancer patients with positive axillary lymph nodes. 2)To compare disease-free survival of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin in combination with docetaxel followed by CMF in operable breast cancer patients with positive axillary lymph nodes. (sequential mono-chemotherapy versus polychemotherapy) 3) To compare overall survival of treatment arms. 4)To compare toxicity of treatment arms. 5) To evaluate pathologic and molecular markers for predicting efficacy. 6) Socioeconomic data will be collected in order to be able to perform a socioeconomic analysis by country, when needed.
SponsorSanofi US Services Inc.
Data ProviderSanofi
Partial set or SubsetOriginal Data
Patients in dataset2886
# of Patients Control994
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/1z8y-rc53
CDISC StandardNon standard raw data
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryPrimary objectives: To compare Disease-Free Survival (DFS) of an adjuvant treatment with docetaxel given either sequentially or in combination with doxorubicin and followed by CMF to doxorubicin alone or in combination with cyclophosphamide and followed by CMF in operable breast cancer patients with positive axillary lymph nodes. Secondary objectives: To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin followed by CMF in operable breast cancer patients with positive axillary lymph nodes To compare DFS of an adjuvant treatment with docetaxel in combination with doxorubicin followed by CMF to doxorubicin in combination with cyclophosphamide followed by CMF in operable breast cancer patients with positive axillary lymph nodes To compare DFS of an adjuvant treatment with doxorubicin followed by docetaxel followed by CMF to doxorubicin in combination with docetaxel followed by CMF in operable breast cancer patients with positive axillary lymph nodes, (sequential mono-chemotherapy versus polychemotherapy). To compare overall survival of treatment arms. To compare toxicity of treatment arms. To evaluate pathologic and molecular markers for predicting efficacy. Socioeconomic data will be collected in order to be able to perform a socioeconomic analysis by country, when needed.
ConditionsBreast Neoplasms
Intervention TypeDrug: Doxorubicine + docetaxel sequential
Drug: doxorubicine + cyclophosphamide sequential
Drug: doxorubicine + cyclophosphamide combined
Drug: doxorubicine + docetaxel combined
Drug(s)Drug: doxorubicine + cyclophosphamide sequential
Drug: doxorubicine + cyclophosphamide combined
Drug: Doxorubicine + docetaxel sequential
Drug: doxorubicine + docetaxel combined
Total Enrolled2887
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionA1 - Active Comparator
A2 - Active Comparator
B - Experimental
C - Experimental
Secondary IDN/A
PubMed (PMID)32614702
22551440
Collaborator(s)N/A
Region(s)Australia
Austria
Belgium
Brazil
Chile
Czech Republic
Denmark
Germany
Hungary
Ireland
Israel
Italy
New Zealand
Portugal
Slovakia
Slovenia
South Africa
Spain
Sweden
Switzerland
United Kingdom
Age Range18 Years to 70 Years (Adult, Older Adult)
Files:
PROTOCOLsanofi_xrp6976d-RP56976_PR_315_protocol_Redacted.pdf
CRFsanofi_xrp6976d-RP56976_PR_315-sample-crf.pdf
DATA DICTIONARYXRP6976_RP56976_PR_315_data_definition.xls
DATA (COMPARATOR ARM)sanofi_XRP6976_RP56976_PR-315.zip
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