6xFU/Epirubicin/Cyclophosphamide (FEC) Compared to 3xFEC-3xDocetaxel in High-risk Node-negative Breast Cancer Patients
This trial is active, not recruiting.
|Treatment||5-fluorouracil, epirubicin, cyclophosphamide, docetaxel|
|Collaborator||German Breast Group|
|Start date||January 2002|
|End date||February 2009|
|Trial size||4150 participants|
|Trial identifier||NCT01222052, GBG 42|
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.
|Intervention model||parallel assignment|
time frame: after 10 years follow up
time frame: after 10 years follow up
Female participants from 18 years up to 70 years old.
- 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
- 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
|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)|
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