NCT01222052Unknown3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 4,150
- 试验地点
- 1
- 主要终点
- Disease-Free Survival
研究概览
简要总结
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.
详细描述
- 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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm A Taxane-containing
Experimental
3 courses FEC q3weeks followed by 3 courses Docetaxel q3weeks
干预措施: 5-Fluorouracil, Epirubicin, Cyclophosphamide, Docetaxel (Drug)
Arm B standard anthracyclin
Active Comparator
6 courses of FEC q3weeks
干预措施: 5-Fluorouracil, Epirubicin, Cyclophosphamide, Docetaxel (Drug)
结局指标
主要结局
Disease-Free Survival
时间窗: after 10 years follow up
次要结局
- Overall Survival(after 10 years follow up)
研究者
Christoph Thomssen
Prof. Dr. Christoph Thomssen
Martin-Luther-Universität Halle-Wittenberg
研究点 (1)
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