ACTRN12607000034437已完成3 期
Adjuvant therapy for post/peri menopausal patients with node positive breast cancer who are not 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5月27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 70 Years（—）
- 性别
- Female
入选标准
- •Post/perimenopausal women with histologically proven primary breast cancer• Positive lymph nodes (metastases detected in one or more of at least 8 ipsilateral axillary nodes examined). Primary tumour must be classified as T1a,b,c ,T2 or T3, pN1, M0.• Patients must be judged not suitable for treatment with endocrine therapy alone. Estrogen receptor status must be known before randomisation• Patients must have had:a) Either total mastectomy or breast conserving procedureb) Axillary clearance with at least 8 lymph nodes available for pathological examinationc) Primary breast cancer surgical procedure must be within 6 weeks prior to randomisation• Tumour must be confined to breast without detected metastases other than those within lymph nodes• Adequate marrow function (WBC > 4.0 x 10^9/l and platelet count > 100 x 10^9/l)• Adequate renal function (serum creatinine < 120umol/l) and hepatic function (serum bilirubin < 20 umol/l, AST (SGOT) < 60 i.u./l)• Informed consent• Geographically accessible for follow-up
排除标准
- •Patients without axillary node involvement• Malignant tumours other than carcinoma• T4 carcinoma with ulceration of skin, infiltration of skin, peau d'orange or inflammatory breast cancer or with distant metastases• Bilateral malignancies, or with mass in opposite breast• Patients in whom the margins of the resected specimen contained tumour cells• Previous or concomitant other malignancy except basal or squamous cell carcinoma of skin or adequately treated in situ carcinoma of cervix• Patients who have received prior therapy for breast cancer including irradiation, chemotherapy or endocrine therapy• Patients with non-malignant systemic diseases preventing them from undergoing any of the treatment options or prolonged follow-up• Patients with psychiatric or addictive disorders preventing them from giving them informed consent• Bone scan showing hot spots which cannot be confirmed as benign disease
研究者
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