NCT00102219已完成2 期
A Phase 2 Study of ALIMTA Plus Doxorubicin Administered Every 21 Days in Patients With Advanced Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 12
- 主要终点
- To assess the antitumor activity of pemetrexed plus doxorubicin, as measured by overall tumor response rate
研究概览
简要总结
This is a non-randomized Phase 2 study testing pemetrexed and doxorubicin in combination for locally advanced or metastatic breast cancer. Both pemetrexed and doxorubicin 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. However, there is no guarantee that the patient will benefit from this treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 that is not amenable to local treatment.
- •Patients must be chemo-naive or have received only neoadjuvant and/or adjuvant chemotherapy.
- •At least one measurable lesion.
- •No chemotherapy within 4 weeks prior to enrollment.
- •Signed informed consent from the patient.
排除标准
- •Prior chemotherapy for metastatic breast cancer.
- •Prior treatment with any anthracyclines or anthracenedione-containing regimen.
- •Treatment within the last 30 days with any drug that has not received regulatory approval.
- •Pregnancy and/or breast feeding.
- •Inability or unwillingness to take folic acid or vitamin B12 supplementation.
结局指标
主要结局
To assess the antitumor activity of pemetrexed plus doxorubicin, as measured by overall tumor response rate
次要结局
- Time to progressive disease
- Progression-free survival
- Overall survival
研究者
研究点 (12)
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