ISRCTN18543567已完成3 期
MINDACT (Microarray In Node-negative Disease may Avoid Chemotherapy): a prospective, randomised study comparing the 70-gene signature with the common clinical-pathological criteria in selecting patients for adjuvant chemotherapy in node-negative breast cancer
European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)0 个研究点目标入组 6,000 人开始时间: 2008年3月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6,000
研究概览
简要总结
2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23777535 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •To be eligible for the MINDACT trial patients will have to comply with the following eligibility criteria, which demonstrate that the patients have early non-metastatic breast cancer:
- •1. Women with histologically proven operable invasive breast cancer and a negative sentinel node or negative axillary clearance (N0, M0). Acceptable primary treatment options are:
- •1.1. Breast conserving surgery or mastectomy with either a sentinel node procedure or full axillary clearance
- •1.2. Radiotherapy is mandatory in the case of breast conserving surgery and will be administered according to local institutional policy after mastectomy
- •1.3. Patients with unresectable positive deep margins who receive adjuvant radiotherapy are eligible provided that all other margins are negative
- •2. A tumour clinical classification of T1, T2 or operable T3
- •3. The breast tumour must be unilateral, however ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) are allowed if invasive cancer is present
- •4. A frozen tumour sample (not fixed in formalin) must be available for inclusion. The tumour sample must be taken from the excised primary tumour (a core punch biopsy).
- •5. Patients should: be aged between 18 and 70 years at randomisation (elderly patients for whom adjuvant treatment is considered could be offered participation in one of the BIG Elderly trials)
- •6. Have a World Health Organization (WHO) performance status of 0 or 1
- •7. Have adequate bone marrow reserves (neutrophil count greater than 1.5 x 10^9/l and platelet count greater than 100 x 10^9), adequate renal function (creatinine clearance greater than or equal to 50 mL/min [calculated according to Cockroft and Gault], or serum creatinine less than or equal to 1.5 x upper limit of normal), hepatic function (alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT] less than or equal to 2.5 x upper limit of normal, alkaline phosphatase less than or equal to 2.5 x upper limit of normal, total bilirubin less than or equal to 2.0 x upper limit of normal) and normal electrocardiogram (ECG) compatible with chemotherapy administration
- •8. While taking study medications patients should take adequate birth control measures which result in low failure rates (i.e. less then 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices (IUDs), sexual abstinence or vasectomised partner (Note 3 of the guidance on non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals CPMP/ICH/286/95)
- •9. Signed written informed consent must be given according to International Conference on Harmonisation Good Clinical Practice (ICH GCP), and national/local regulatory requirements before enrolment in the trial (both a screening patient information sheet [PIS] and informed consent [IC] and the PIS and IC 1 must be signed before enrolment)
- •Patients will be eligible for inclusion in the chemotherapy randomisation (R-C) if they meet all of the general eligibility criteria AND the following criteria:
- •10. Women who have:
- •10.1. A high risk of recurrence according to both the clinical-pathological criteria and the 70-gene signature, or
- •10.2. A high risk acco
排除标准
- •1. Serious cardiac illness or medical condition including but not confined to:
- •1.1. A history of documented congestive heart failure (CHF)
- •1.2. High-risk uncontrolled arrhythmias
- •1.3. Angina pectoris requiring antianginal medication
- •1.4. Clinically significant valvular heart disease
- •1.5. Evidence of transmural infarction on ECG
- •1.6. Poorly controlled hypertension (e.g. systolic blood pressure [BP] greater than 180 mmHg or diastolic BP greater than 100 mmHg)
- •1.7. Symptomatic coronary artery disease
- •1.8. A myocardial infarction
- •Within the last 12 months or other risk factors that contra-indicate the use of anthracycline-based chemotherapy
- •2. Previous or concurrent cancer, possible exceptions are:
- •2.1. Adequately treated carcinoma in situ of the cervix
- •2.2. Non-melanoma skin cancer
- •2.3. Any cancer (other than breast cancer) in complete remission for greater than or equal to five years
- •3. Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
- •4. Received previous chemotherapy, hormonal therapy or radiotherapy
- •5. Participated in any investigational drug study within the four weeks preceding the start of treatment
- •6. Be pregnant or breast-feeding at the time of diagnosis or randomisation. A woman of childbearing potential must have a negative pregnancy test. If post-menopausal, the woman must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential.
- •7. 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 enrolment in the trial.
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