NCT00334802已完成2 期
Combination Study of LY188011 and Paclitaxel in Patients With Metastatic/Recurrent Breast Cancer After Neo-adjuvant/Adjuvant Chemotherapy With Anthracycline
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Tumor Response
研究概览
简要总结
To investigate efficacy, safety and PK of gemcitabine and paclitaxel combination in patients with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline regimen
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
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically and/or cytologically confirmed breast cancer
- •Received adjuvant/neo-adjuvant chemotherapy for breast cancer with anthracycline regimen
- •To have at least one measurable region
- •Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- •To have adequate organ function (bone marrow, liver and renal function)
排除标准
- •To have interstitial pneumonia or pulmonary fibrosis
- •To have inflammatory breast cancer
- •Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
- •To have brain metastases with symptoms
- •To have severe complication (cardiac infarction, infection, drug hypersensitivity or diabetes)
研究组 & 干预措施
A
Experimental
干预措施: gemcitabine (Drug)
A
Experimental
干预措施: paclitaxel (Drug)
结局指标
主要结局
Tumor Response
时间窗: baseline to measured progressive disease
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. Responders are patients with complete response or partial response.
次要结局
- Duration of Response(time of response to progressive disease)
- Time to Progressive Disease(baseline to measured progressive disease)
- Number of Participants Alive at One Year (1-Year Survival)(baseline to date of death from any cause, evaluated at 1 year)
- Pharmacokinetics - Maximum Plasma Concentration (Cmax)(cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes))
- Pharmacokinetics - Area Under the Concentration Curve (AUC)(cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes))
- Pharmacokinetics - Half Life (t½)(cycle 1, day 1 (0 minutes, 3, 3.25, 3.5, 3.58, 3.75, 4, 4.5, 5 hours) and 8 (0, 15, 30, 35, 45, 60, 90, 120 minutes))
研究者
研究点 (1)
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