ACTRN12606000532505已完成3 期
Adjuvant therapy for post/perimenopausal patients with node positive breast cancer who have oestrogen receptor positive tumours
International Breast Cancer Study Group0 个研究点目标入组 960 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
- 960
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
- ot stated 至 70 Years（—）
- 性别
- Female
入选标准
- •Post/perimenopausal women - Patients with positive lymph nodes (metastases detected in one or more of at least 8 ipsilateral axillary nodes examined)- Patients must be judged suitable for treatment with endocrine therapy alone. As a minimum, patients must have estrogen receptor positive tumours. (ER >= 10 fmol/mg cytosol protein or judged to be ER positive by immunohistochemical evaluation)- Patients must have had:a) Either total mastectomy or, optionally if the tumour was <= 5cm, a breast-conserving procedure (lumpectomy or quadrantectomy) b) Axillary clearance (not sampling) with at least eight lymph nodes available for pathological examinationc) The primary breast cancer surgical procedure within six weeks prior to randomisation- Minimum of eight lymph nodes histopathologically examined with at least one found positive- Tumour confined to the breast with no detected metastases - Adequate bone marrow function (WBC >= 4.0 x 10^9/L and platelets >+ 100 x 10^9/L)- Documented evidence of adequate renal function (creatinine < 120umol/L) and hepatic function (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 the skin, peau d'orange or inflammatory breast cancer, or with distant metastases- Bilateral malignancies, or mass in opposite breast- Margins of resected specimen contained tumour cells- Estrogen-receptor negative 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- Other non-malignant systemic disease 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
研究者
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