Trial | NCT01222052  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    4150
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.
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

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)
Study Started
Jan 31
2002
Primary Completion
Feb 28
2009
Study Completion
Feb 28
2019
Anticipated
Last Update
Jun 26
2017

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

Arm A Taxane-containing Experimental

3 courses FEC q3weeks followed by 3 courses Docetaxel q3weeks

Arm B standard anthracyclin Active Comparator

6 courses of FEC q3weeks

Observation No Intervention

Criteria 

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
No Results Posted