A Phase II Study of Alimta as First Line Chemotherapy for Advanced or Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Overall Tumor Response
研究概览
简要总结
The purposes of this study are to determine whether pemetrexed can help patients with metastatic (cancer that has spread to other parts of the body) breast cancer, to determine any side effects that may be associated with the drug, to determine how much pemetrexed should be given to patients, and to collect DNA for future research regarding metastatic breast cancer. The collection of DNA is optional to the patient.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Must have been diagnosed with either advanced or metastatic breast cancer.
- •Chemotherapy has not been given for advanced or metastatic breast cancer.
- •The diagnosis of advanced or metastatic breast cancer was made at least 12 months after chemotherapy was given after breast surgery.
- •Able to carry out work of a light nature (for example, light housework, office work).
- •Must be at least 18 years old.
排除标准
- •Have received prior bone marrow or peripheral stem cell transplantation.
- •Have received prior chemotherapy for metastatic breast cancer.
- •Are currently pregnant or breast-feeding.
- •Have an active infection that your doctor decides will affect your safety.
- •Are unable to take folic acid or vitamin B12.
研究组 & 干预措施
A
干预措施: pemetrexed (Drug)
结局指标
主要结局
Overall Tumor Response
时间窗: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
次要结局
- Overall Survival Time(every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up)
- Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)(every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up)
- Duration of Tumor Response(every 3 cycles (approximately 6-7 weeks) or until patient has disease progression)
- Progression-Free Survival Time(every 3 cycles (approximately 6-7 weeks) or until patient has disease progression)