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Available in the Gosset platform where reported.
01
Overview
Phase 3, randomised, open-label trial of docetaxel in breast cancer (3 arms), sponsored by Sanofi. Primary endpoint: Invasive Disease-Free Survival. Started Dec 1997; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
Epi -> CMF
Sequential Epidoxorubicin followed by CMF
Epi -> Doc -> CMF
Sequential Epidoxorubicin followed by Docetaxel followed by CMF
Intensified Epi -> Doc -> HD-CTX
Sequential Intensified Epidoxorubicin followed by Docetaxel followed by High-Dose Cyclophosphamide
03
Who it enrols
Patients with histologically proven node-positive (>= 4 nodes) breast adenocarcinoma, aged 18-70 (18-65 for Arm C), with adequate organ function and no prior systemic anticancer therapy.
04
Endpoints
Primary
Invasive Disease-Free Survival
Secondary
Recurrence-Free Survival
Overall Survival
Distant Disease-Free Survival
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Competitive context
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