Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment 5-fluorouracil, epirubicin, cyclophosphamide, docetaxel
Phase phase 3
Sponsor Martin-Luther-Universität Halle-Wittenberg
Collaborator German Breast Group
Start date January 2002
End date February 2009
Trial size 4150 participants
Trial identifier NCT01222052, GBG 42

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
3 courses FEC q3weeks followed by 3 courses Docetaxel q3weeks
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
(Active Comparator)
6 courses of FEC q3weeks
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
(No Intervention)

Primary Outcomes

Measure
Disease-Free Survival
time frame: after 10 years follow up

Secondary Outcomes

Measure
Overall Survival
time frame: after 10 years follow up

Eligibility Criteria

Female participants from 18 years up to 70 years old.

Inclusion Criteria: - Histological proven primary breast cancer - Tumour size >0.5 cm and <5 cm (pT1b-pT2, pN0, M0) - Axillary lymph nodes tumour free (node-negative disease) - Adequate surgical procedure: R0-resection and axillary dissection with more than 10 lymph nodes examined or adequate sentinel procedure in a qualified centre - Frozen tumour tissue available (for analysis of biological markers and microarrays, centres with biological risk assessment only). The material has to be stored in liquid nitrogen immediately after excision. - Paraffin blocks or (at least) pathology slides of primary tumour (stained and unstained) and axillary nodes (stained) available for central review. - HER-2/neu determination by immunohistochemistry. Patients will be stratified to be HER-2/neu-negative or HER-2/neu-positive (HER-2/neu Score 3+, or HER-2/neu Score 2+ and FISH positive). - No distant metastasis - Age >18 years, <70 years - Performance status ECOG <2 (WHO Performance Status 0-1) - Adequate cardiac function (echocardiographically measured left ventricular ejection fraction (LVEF) or shortening fraction (SF) within the normal limits, i.e. ≥55%) - Adequate bone function (neutrophil count >1.5 x109 /l and platelet count >100 x109 /l) - Adequate renal function (serum creatinine <120 µmol/l or 1.35 mg/dl) and hepatic function (serum bilirubin <1 x UNL, ASAT or ALAT (SGOT or SGPT) <2,5 x UNL) - Before patient registration/randomization, written informed consent must be obtained according to ICH/EU GCP, and national/local regulations Exclusion Criteria: - Chemotherapy contraindicated - Inflammatory breast cancer, tumour infiltrated axillary lymph nodes including the sentinel node. - Other concomitant pathology compromising survival (at entry), or preventing the administration of chemotherapy with either FEC or Docetaxel - Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study - Estimated life-expectancy <10 years (irrespective of breast cancer diagnosis) - Patient not accessible for treatment and follow up - Endocrine treatment not according to the latest standard recommendations of the AGO Kommission "Mamma" - Pregnancy, lactation (sufficient non-hormonal contraception in fertile women required) - Surgery more than six weeks ago at the start of chemotherapy - Pre-existing polyneuropathy - Previous or concomitant other malignancy (including contralateral breast cancer) except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix - Prior chemotherapy or radiotherapy or endocrine therapy

Additional Information

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
Principal investigator Christoph Thomssen, MD
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)
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by Martin-Luther-Universität Halle-Wittenberg.