EUCTR2008-005453-38-DE进行中（未招募）1 期
Simultaneous Study of Docetaxel Based Anthracycline FreeAdjuvant Treatment Evaluation, as well as Life Style InterventionStrategiesSUCCESS C-Trial - Success-C
niversitätsklinikum Ulm0 个研究点目标入组 3,547 人开始时间: 2008年10月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,547
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •[1.] Primary epithelial invasive carcinoma of the breast pT1-4, pN0-3, pM0
- •[2.] No evidence of HER2/neu overexpressing (IHC neg or +) or amplifying (FISH -
- •[3.] Histopathological proof of axillary lymph node metastases (pN1-3) or high risk
- •node negative, defined as at least one criterion of the following: ‘pT2,
- •histopathological grade 3, age <= 35, negative hormone receptor’
- •[4.] Complete resection of the primary tumor with margins of resection free of
- •invasive carcinoma not more than 6 weeks ago
- •[5.] Females >=18 years of age
- •[6.] Performance status <= 2 on ECOG-Scale
- •[7.] Adequate bone marrow reserve: leucocytes >= 3.0 x 109/l and platelets >= 100 x
- •[8.] Bilirubin within the reference laboratory’s normal range, ASAT (SGOT), ALAT
- •(SGPT) and AP within 1,5 fold of the reference laboratory’s normal range for
- •[9.] Willingness to participate in a telephone-based lifestyle intervention program
- •[10.] Intention of regular follow up visits for the duration of the study
- •[11.] Ability to understand the nature of the study and to give written informed
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •[12.] Inflammatory breast cancer
- •[13.] Previous or concomitant cytotoxic or other systemic antineoplastic treatment
- •which is not part of this study
- •[14.] A second primary malignancy (except in situ carcinoma of the cervix or
- •adequately treated basal cell carcinoma of the skin)
- •[15.] Cardiomyopathy with impaired ventricular function (NYHA > II), cardiac
- •arrhythmias influencing LVEF and requiring medication, history of myocardial
- •infarction or angina pectoris within the last 6 months, or arterial hypertension not
- •being controlled by medication
- •[16.] Any known hypersensitivity against Docetaxel, Epirubicine,
- •Cyclophosphamide, or any other medication included in the study protocol. The
- •contraindication, warning notices and measures of precaution of the products, as
- •notified in the product infroamtion, have to be respected
- •[17.] Use of any investigational agent within 3 weeks prior to inclusion
- •[18.] Patients in pregnancy or breast feeding (in premenopausal women
- •anticonception has to be assured)
- •[19.] Insulin-requiring diabetes mellitus (non-insulin requiring patients with type 2
- •diabetes are eligible for the study)
- •[20.] Serious digestive and/or absorptive problems that exclude adherence to the
- •[21.] Self-reported inability to walk at least one kilometre (at any pace)
- •SUCCESS C Trial, Version 1.0, 08.09.2008 Page 59
- •[22.] Cardiovascular, respiratory or musculoskeletal disease or joint problems that
- •preclude moderate physical activity. Moderate arthritis that does not preclude
- •physical activity is not a reason for exclusion
- •[23.] Psychiatric disorders or conditions that would preclude participation in the
- •study intervention
- •[24.] Patients not sufficiently fluent in German language to understand the nature of
- •this study and any of the interventional measures
研究者
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