Spots Global Cancer Trial Database for 6xFU/Epirubicin/Cyclophosphamide (FEC) Compared to 3xFEC-3xDocetaxel in High-risk Node-negative Breast Cancer Patients

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Trial Identification

Brief Title: 6xFU/Epirubicin/Cyclophosphamide (FEC) Compared to 3xFEC-3xDocetaxel in High-risk Node-negative Breast Cancer Patients

Official Title: Randomized Multicenter Study Comparing 6xFEC With 3xFEC-3xDoc in High-risk Node-negative Patients With Operable Breast Cancer: Comparison of Efficacy and Evaluation of Clinico-pathological and Biochemical Markers as Risk Selection Criteria

Study ID: NCT01222052

Conditions

Breast Cancer

Interventions

5-Fluorouracil, Epirubicin, Cyclophosphamide, Docetaxel

Study Description

Brief Summary: In low-risk node-negative breast cancer patients adjuvant chemotherapy should be spared. The identification of this subgroup can be based either on clinical and pathological or on tumour-biological criteria. Due to their high prognostic impact, the tumour-biological invasion markers uPA/PAI-1 (urokinase-type plasminogen activator and its inhibitor PAI-1) are potential candidates to effectively assess the risk of relapse in node-negative breast cancer. This study is aimed to compare the risk assessment by the traditional clinico-pathological factors and by tumour-biological factors. The second study question refers to the comparison between an adjuvant combination treatment with FE100C\*6 and a sequential treatment with FE100C\*3 and Docetaxel\*3.

Detailed Description: 1. To compare FEC\*6 with FEC\*3 followed by DOC\*3 with regard to: * the primary endpoint of the study: Disease-Free Survival (DFS) * the secondary endpoints: Overall Survival (OS), compliance, and toxicity of chemotherapy in each patient group 2. To compare patients with low risk according to clinico-pathological versus those according to biological risk criteria with regard to: * the proportion of low risk versus high risk patients * DFS * OS (secondary endpoint)