ACTRN12606000379516已完成3 期
A phase III trial to evaluate oral chemotherapy with Capecitabine versus standard chemotherapy with CMF in advanced breast cancer
Breast Cancer Trials (formerly Australian New Zealand Breast Cancer Trials Group)0 个研究点目标入组 325 人开始时间: 2003年12月17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
- 325
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
- •Histologic or cytologic diagnosis of breast cancer with at least one of the following: distant metastasis (including just supraclavicular nodes), local invasion of adjacent non-breast tissue ie T4 or N2 or N3, local recurrence following mastectomy; Treatment with palliative intent, i.e. without realistic hope of cure; Suitable for protocol chemotherapy with either CMF or capecitabine; ECOG performance status of 0 to 3; Neutrophil count greater than or equal to 1.5 x 10 (9)/L and Platelet count greater than or equal to 75 x 10 (9)/L; Creatinine clearance greater than or equal to 30 mL/minute according to the Cockcroft-Gault Formula; Serum total bilirubin <50 umol/L; Accessible for treatment and follow-up; Written informed consent; Baseline HRQL forms completed OR the patient cannot read English.
排除标准
- •Previous chemotherapy for advanced breast cancer; Less than 6 months following the last dose of adjuvant chemotherapy; Unsuitable for protocol therapy with either CMF or capecitabine, e.g. side effects with 5 FU suggestive of dihydropyrimidine dehydrogenase deficiency; GI disease precluding oral chemotherapy; serious uncontrolled infection; Indication for chemotherapy more intensive than CMF or capecitabine; Brain and/or leptomeninges as the only sites of documented disease; Age <18 years (there is no upper age limit); Pregnant or breast-feeding women; Investigational drug therapy within 30 days prior to randomisation; Concurrent anticancer therapy (any radiation must be completed at least 4 weeks before randomisation); Other malignancy within the last 5 years except adequately treated basal cell or squamous cell carcinoma of skin or in-situ carcinoma of the cervix; Treatment with the antiviral agent sorivudine, or related compounds such as brivudine
研究者
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