ACTRN12607000022460已完成3 期
Adjuvant therapy in node positive pre/perimenopausal breast cancer patients: CMF 3 vs. 6 with or without reintroduction of chemotherapy.
International Breast Cancer Study Group0 个研究点目标入组 1,554 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
- 1,554
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 o limit（—）
- 性别
- Female
入选标准
- •a) >52 years, and LNMP (last normal menstrual period) within 1 year OR b) <=52 years, and LNMP within 3 years, or currently menstruating OR c) <=55 years, and hysterectomy without bilateral oophorectomy OR d) Biochemical confirmation of continuing ovarian function (in questionable cases); All N+ patients with ER status determined for stratification; Tumour confined to breast with or without metastatic spread limited to ipsilateral axilla; Axillary nodes were not fixed and there was no arm oedema; WBC is >= 4,000/mm^3 and platelet count is >= 100,000/mm^3; Documented evidence of adequate renal ( creatinine < 120umol/L) and hepatic (bilirubin < 20umol/L, SGOT < 60 iu/L) function; Patients must give consent to be in study and be geographically accessible for follow-up; UICC performance status of 0 – 2; Either total mastectomy, quadrantectomy or lumpectomy with axillary clearance, performed no earlier than 6 weeks (addendum 2, previously 4 weeks) before randomization; A minimum of 8 lymph nodes has been histologically examined
排除标准
- •Malignant breast tumours other than carcinoma; Inflammatory carcinoma, with ulceration or infiltration of skin, or peau d'orange; T3b ot T4 breast carcinoma, or N2 or N3 nodal status; Bilateral malignancies, or mass in opposite breast; Less than total mastectomy procedures; Pregnant or lactating women; Previous or concomitant malignancy; Prior therapy for breast cancer; Clinically positive nodes in axilla opposite to affected breast; Other non-malignant systemic diseases preventing treatment options/follow-up; Psychiatric or addictive disorders preventing informed consent; Premenopausal patients with ER+ primary tumours; Bone scintigrams showing hot spots which cannot be confirmed as benign disease; N- patients (Addendum 1)
研究者
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