NCT00097383已完成1 期
A Phase 2 Study of Alimta and Epirubicin Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 24
研究概览
简要总结
This is a non-randomized Phase 2 portion of a study testing ALIMTA and epirubicin in combination for locally advanced or metastatic breast cancer. Epirubicin is a well-established drug for the therapy of breast cancer. Both ALIMTA and epirubicin have been combined with other drugs but they have not yet been combined with each other. It is expected that the patient will benefit from the different mechanisms of action of the two drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of locally advanced or metastatic breast cancer not amenable to local treatment.
- •Patients must be chemo-naive or have only neoadjuvant and/or adjuvant chemotherapy.
- •Patients must have at least one measurable lesion in an area not previously irradiated.
- •No chemotherapy at least 4 weeks prior to study enrollment.
- •Signed informed consent from patient.
排除标准
- •Treatment with any drug within the last 30 days that has not received regulatory approval.
- •Serious systemic disorders, including active infection.
- •Significant cardiovascular disease.
- •Pregnancy or breast feeding.
- •Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
研究者
研究点 (24)
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