EUCTR2012-002707-18-IT进行中（未招募）不适用
EFFECT: A randomized phase II study to evaluate the EFficacy and impact on Function of two different doses of nab-paclitaxEl in elderly patients with advanCed breasT cancer - EFFECT
FONDAZIONE SANDRO PITIGLIANI PER LA LOTTA CONTRO I TUMORI-ONLUS0 个研究点开始时间: 2012年10月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Histologically or cytologically confirmed breast cancer, locally recurrent and/or metastatic; any estrogen/progesterone receptor status; HER2 receptor negative OR HER2 positive but with contraindication to anti-HER2 therapy (e.g. known congestive cardiac failure).
- •Measurable disease or non-measurable but evaluable disease according to RECIST 1.1 criteria (see Appendix B) [Eisenhauer]
- •Age = 65 years
- •ECOG performance status 0-2
- •Estimated life expectancy of = 12 weeks
- •oStaging CT or MRI brain is required only if clinically indicated
- •Adequate organ function
- •No significant peripheral neuropathy (significant peripheral neuropathy is defined as = grade 2 on CTCAE v4.0 criteria)
- •No clinically significant comorbidities including: uncontrolled cardiac arrhythmias (with the exception of rate-controlled atrial fibrillation), NYHA class III or IV cardiac failure, uncontrolled diabetes, hypertension or other medical conditions that may interfere with assessment of toxicity
- •No other malignancy within the last 5 years, with the exception of adequately treated non-melanomatous skin cancers, cervical intraepithelial neoplasia or cervical carcinoma in situ
- •No requirements for concomitant medications or therapies that may potential interact with the trial agent. Any prohibited medication must be discontinued at least 14 days prior to trial entry
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 156
排除标准
- •- active/symptomatic CNS metastases
- •- previous chemotherapy for breast cancer in the advanced setting
研究者
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