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Doxorubicine+ docetaxel sequential

Phase 3

Breast Neoplasms | Small molecule | Oncology |Sanofi|Last Updated: Nov 10, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment2,887

FDA Designations

No designations recorded

Clinical trial landscape

Doxorubicine+ docetaxel sequential · 1 trial · 1 indication

Phase 3 1
NCT00174655BIG 02/98 Docetaxel - Breast CancerBreast Neoplasms
COMPLETED2,887 Analytics
PHASE3COMPLETED
BIG 02/98 Docetaxel - Breast Cancer
Breast NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

DFS of docetaxel arms versus non toxanes arm (DFS: interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death for any cause whichever occurs first.
810 events or median 5 year follow-up whichever occurs first

Secondary Endpoints

DFS sequential/combined arms
810 events or median 5 year follow-up whichever occurs first
Safety NCI common toxicity criteria
from baseline to study end
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
A1ACTIVE_COMPARATOR -
A2ACTIVE_COMPARATOR -
BEXPERIMENTAL -
CEXPERIMENTAL -

Interventions

NameTypeDescription
Doxorubicine + docetaxel sequentialDRUGdoxorubicin 75 mg/m² i.v. day 1, q 21 days for 3 cycles, followed by docetaxel 100 mg/m² i.v., 1 hour infusion, day 1, q 21 days for 3 cycles, followed by CMF for 3 cycles
doxorubicine + cyclophosphamide sequentialDRUGdoxorubicin 75 mg/m² i.v. day 1 q 21 days for 4 cycles, followed by CMF (C: cyclophosphamide 100 mg/m² orally days 1-14, M: methotrexate: 40 mg/m² i.v. days 1 and 8, FU; 5-fluorouracil: 600 mg/m²) i.v. days 1 and 8, q 28 days for 3 cycles
doxorubicine + cyclophosphamide combinedDRUGdoxorubicin 60 mg/m² i.v. + cyclophosphamide 600 mg/m² i.v., day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles.
doxorubicine + docetaxel combinedDRUGdoxorubicin 50 mg/m² i.v. + docetaxel 75 mg/m² i.v. 1 hour infusion (1 hour after doxorubicin), day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Histologically proven breast cancer. Interval between definitive surgery that includes axillary lymph node dissection and registration must be less than 60 days. A representative sample of the primary tumor (either blocks or slides) must be sent to the operational office, for ...

Countries:AustraliaAustriaBelgiumBrazilChileCzechiaDenmarkGermanyHungaryIrelandIsraelItalyNew ZealandPortugalSlovakiaSloveniaSouth AfricaSpainSwedenSwitzerlandUnited Kingdom
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