ACTRN12606000534583已完成3 期
Adjuvant therapy for premenopausal patients with node positive breast cancer who are suitable for endocrine therapy alone
International Breast Cancer Study Group0 个研究点目标入组 760 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
- 760
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
- •Premenopausal women with histologically proven primary breast cancer• Positive lymph nodes (metastases detected in 1 or more of at least 8 ipsilateral axillary nodes examined). The primary tumour must be classified as T1a,b,c T2 or T3, pN1, M0 (UICC 1987)• Patients must be judged suitable for treatment with endocrine therapy alone. As a minimum, must have ER positive tumours (ER>= 10 fmol/mg cytosol protein) or PR positive tumours (PgR>= 10 fmol/my cytosol protein)• Patients must have had:a) Either total mastectomy or, optionally if the tumour is <=5cm, breast-conserving procedure (lumpectomy or quadrantectomy)b) Axillary clearance with at least eight lymph nodes available for pathological examinationc) The primary breast cancer surgical procedure must be within 6 weeks prior to randomisation• Minimum of 8 lymph nodes histopathologically examined with at least one found positive• Tumour must be confined to breast without detected metastases• Adequate marrow function (WBC >= 4.0 x 10^9/L and platelet count >= 100 x 10^9/L)• Adequate renal function (serum creatinine < 120 umol/L) and hepatic function (serum bilirubin < 20umol/L, AST (SGOT) < 60 i.u./L)• Informed consent• Geographically accessible for follow-up
排除标准
- •Patients without axillary node involvement• Malignant breast tumours other than carcinoma• T4 carcinoma with ulceration, infiltration of skin, peau d'orange or inflammatory breast cancer• Bilateral malignancies, or mass in opposite breast• Margins of resected specimen contained tumour cells• ER- and PR- tumours• Previous or concomitant other malignancy except basal or squamous cell carcinoma of skin or in situ carcinoma of cervix• Prior therapy for breast cancer• Non-malignant systemic diseases preventing treatment options or follow-up• Psychiatric or addictive disorders preventing informed consent• Bone scans showing hot spots which cannot be confirmed as benign disease• Pregnant or lactating
研究者
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