EUCTR2005-002625-31-PT进行中（未招募）不适用
MINDACT (Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy):A prospective, randomized study comparing the 70-gene signature with the common clinical-pathological criteria in selecting patients for adjuvant chemotherapy in breast cancer with 0 to 3 positive nodes. (EORTC 10041 BIG 3-04) - MINDACT
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 6,000 人开始时间: 2010年5月28日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6,000
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
- •Women with histologically proven operable invasive breast cancer, 0 to 3 positive nodes and no distant metastases.
- •Acceptable treatment options are:
- •Breast conserving surgery or mastectomy with either a sentinel node procedure or full axillary clearance.
- •Radiotherapy is mandatory in the case of breast conserving surgery and will be administered according to local institutional policy after mastectomy.
- •Patients with unresectable positive deep margins who receive adjuvant radiotherapy are eligible provided that all other margins are negative.
- •With a clinical tumor classification of T1, T2 or operable T3.
- •The breast tumor must be unilateral. Multi focal tumors are allowed provided that they have identical histology. DCIS or LCIS are allowed if invasive cancer is present.
- •A frozen tumor sample (not fixed in formalin) must be available for inclusion. The tumor sample must be a core punch biopsy taken from the excised primary tumor.
- •Patients should be aged between 18 and 70 years at randomization. (Elderly patients for whom adjuvant treatment is considered could be offered participation in one of the BIG Elderly trials.)
- •Have a WHO performance status of 0 or 1.
- •have adequate bone marrow reserves (neutrophil count >1.5 x109 /l and platelet count >100 x109), adequate renal function (serum creatinine = 1.5 x upper limit of normal) and hepatic function (ALAT, ASAT = 2.5 x upper limit of normal, alkaline phosphatase = 2.5 x upper limit of normal and total bilirubin = 2.0 x upper limit of normal).
- •have no serious cardiac illness or medical condition including but not confined to: a history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring antianginal medication, clinically significant valvular heart disease, evidence of transmural infarction on ECG, poorly controlled hypertension (e.g. systolic > 180 mm Hg or diastolic > 100 mm Hg), symptomatic coronary artery disease or a myocardial infarction within the last 12 months or other risk factors that contra-indicate the use of anthracycline-based chemotherapy.
- •while taking study medications patients should take adequate birth control measures such as highly effective methods as defined by the Note 3 of the note for guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals (CPMP/ICH/286/95):
- •A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less then 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
- •Signed written informed consent must be given according to ICH GCP, and national/local regulations before enrollment in the trial (Both the screening PIS & IC and PIS & IC 1 must be signed before enrollment).
- •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
- •Have serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease.
- •Have previous or concurrent cancer, possible exceptions are; adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, and any invasive cancer (other than breast cancer) in complete remission for = 5 years.
- •Have received previous chemotherapy, hormonal therapy or radiotherapy.
- •Have participated in any investigational drug study within the 4 weeks preceding the start of treatment.
- •Be pregnant or lactating at the time of diagnosis or randomization. A woman of childbearing potential must have a negative pregnancy test. If post-menopausal, the woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential
- •Have any psychological, familial, sociological, geographical or serious uncontrolled medical (e.g. a history of uncontrolled seizures, central nervous system disorders, or psychiatric disability) condition judged by the investigator to be clinically significant which could potentially preclude informed consent or interfere with compliance for oral drug intake or with the study protocol and follow-up schedule. These conditions should be discussed with the patient before registration in the trial.
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