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epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile

Phase 3

Breast Neoplasms | Small molecule | Oncology |Sanofi|Last Updated: Dec 7, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment998

FDA Designations

No designations recorded

Clinical trial landscape

epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile · 1 trial · 1 indication

Phase 3 1
NCT00174707Study of Docetaxel in Breast Cancer PatientsBreast Neoplasms
COMPLETED998 Analytics
PHASE3COMPLETED
Study of Docetaxel in Breast Cancer Patients
Breast Neoplasms
NCT00174707998
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Study Endpoints

Primary Endpoints

Invasive Disease-Free Survival (IDFS) - with exclusion of ductal carcinoma in situ- DCIS- either collateral or ipsilateral, according to STEEP in adjuvant breast cancer trial: Standardized Definitions for Efficacy Endpoints
Time between randomization date and date of local or distant recurrence or contralateral breast cancer or second primary (non breast) cancer or death from any cause, whichever occurs first

Secondary Endpoints

Recurrence-Free Survival (RFS)
Time between the date of randomization and the date of local or distant recurrence or death from any cause, whichever occurs first, thus excluding contralateral breast cancer or second primary (non breast) cancers
Overall Survival (OS)
Time between the date of randomization and date of death
Distant Disease-Free Survival (DDFS)
Time betwen the date of randomization and the date of distant recurrence or death from any cause, whichever occurs first
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AACTIVE_COMPARATORSequential Epidoxorubicin followed by CMF: ciclophosphamide/Methotrexate/fluorouracile (±TAM: tamoxifen)
BEXPERIMENTALSequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM)
CEXPERIMENTALSequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM)

Interventions

NameTypeDescription
epidoxorubicine, ciclophosphamide, methotrexate, fluorouracileDRUGSequential Epidoxorubicin followed by ciclophosphamide/Methotrexate/fluorouracile (±TAM)
epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracileDRUGSequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM)
epidoxorubicine, docetaxel, cyclophosphamideDRUGSequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM)
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Eligibility Criteria

Age Range18 Years to 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Histologically proven breast cancer at the first diagnosis with \> or = 4 axillary nodes showing evidence of tumor among a minimum of 10 resected lymph nodes (American Joint Committee on Cancer 1992 pathologic staging pT1-4, pN1-2 \[at least 1/10\], M0) * Ages ≥ 18 years and ≤...

Countries:Italy
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