NCT01222052

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,150 (actual)
• Sponsor: Martin-Luther-Universität Halle-Wittenberg · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	5-Fluorouracil, Epirubicin, Cyclophosphamide, Docetaxel	Arm A 5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 q3weeks followed by Docetaxel 100 mg/m² q3weeks Arm B 5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 q6weeks

Timeline

• Start date: 2002-01-01
• Primary completion: 2009-02-01
• Completion: 2019-02-01
• First posted: 2010-10-18
• Last updated: 2017-06-26

Locations

1 site across 1 country: Germany