ACTRN12607000029493已完成3 期
Adjuvant therapy in postmenopausal patients with node negative breast cancer
International Breast Cancer Study Group0 个研究点目标入组 900 人开始时间: 1994年11月3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
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- Female
入选标准
- •Postmenopausal women who are:a) > 52 years, with at least 1 year amenorrhea; orb) < or equal to 52 years with 3 or more years of amenorrhea; or c) > 55 years and have had hysterectomy without bilateral oophorectomy; ord) Biochemical evidence of cessation of ovarian function (in questionable cases)Patients must have had:a. Either total mastectomy, or breast conserving procedure (lumpectomy or quadrantectomy)b. Axillary clearance with at least 8 lymph nodes for pathological examinationc. Surgical procedure within 6 weeks prior to randomisation• Node negative disease (without metastases detected at pathologic examination in at least 8 ipsilateral axillary nodes)• Eight lymph nodes histopathologically examined• Tumour confined to breast with no detected metastases• Adequate marrow function (WBC > 400/mm3 and platelets > 100,000/mm3• Documented evidence of adequate renal (creatinine < 120umol/l) and hepatic (bilirubin < 20umol/l, SGOT < 60 IU/l) function• Informed consent
排除标准
- •Axillary node involvement• Malignant breast tumours other than carcinoma• T4 tumours with ulceration or infiltration of skin, peau d' orange, or metastatic disease• Bilateral malignancies, or mass in opposite breast, unless mass is proven by biopsy to be non-malignant• Less than total mastectomy procedure in which margins of resection contained tumour cells, after which they did not subsequently undergo total mastectomy• Premenopausal patients• Previous or concurrent malignancy, except patients with squamous or basal cell carcinoma of skin, or in-situ carcinoma of cervix• Prior therapy for breast cancer, including irradiation, surgery, or chemo- and/or hormonal therapy• Other non-malignant systemic diseases preventing treatment options or prolonged follow-up• Psychiatric or addictive disorders preventing informed consent or treatment options• Bone scan showing hot spots which cannot be confirmed as benign disease, or skeletal pain of unknown cause• Estrogen receptor negative tumours or are oestrogen receptor status unknown (addendum 12).
研究者
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