NCT02687490已完成2 期
A Prospective, Single-center, Open-Label, Phase II Study of Abraxane in Patients With Visceral Metastases Dominant Metastatic Breast Cancer
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
- 81
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
Abraxane in patients with visceral metastases dominant metastatic breast cancer
详细描述
A Prospective, Single-center, Open-Label, Phase II Study of Abraxane in patients with visceral metastases dominant metastatic breast cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed metastatic breast cancer;
- •Radiologically or histologically confirmed visceral dominant metastases;
- •Patients who are expected to acquire benefit from chemotherapy: ER and/or PR positive patients who developed resistance after prior endocrine therapy; HER2+ patients who experienced disease progression on prior target therapy and are not suitable for subsequent target therapy; mTNBC patients who relapsed after platinum therapy;
- •At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1);
- •Patients who received paclitaxol in metastatic setting should be proven effective to prior paclitaxol based regimen and disease progressed after at least 3 months from the last administration of paclitaxol; those who received paclitaxel as neoadjuvant/adjuvant therapy can be enrolled if disease relapsed after at least 6 months from the completion of neoadjuvant/adjuvant chemotherapy. Patients who received docetaxol have no limitation for enrollment;
- •Eastern Cooperative Oncology Group performance (ECOG) status of 0-1;
- •All patients enrolled are required to have adequate hematologic, hepatic, and renal function;
- •Life expectancy longer than 12 weeks;
- •No medical history of serious cardiovascular, hepatic, respiratory or renal diseases;
- •Informed consent;
- •Patients with good compliance.
排除标准
- •Pregnant, lactating women or women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study;
- •Patients who are expected to acquire benefit from endocrine or target therapy;
- •Radiotherapy of axial bones within 4 weeks before enrollment or lack of recovery from prior radiotherapy;
- •Treatment with other experimental drug within 4 weeks before enrollment;
- •Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to enrollment;
- •Other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia;
- •Patients with a history of symptomatic cardiovascular, hepatic, respiratory, renal , hematological, endocrinal, neurological or psychiatric diseases;
- •Uncontrolled serious infection.
研究组 & 干预措施
Abraxane
Experimental
Abraxane: 125 mg/m2, D1, D8, D15 every 28 days
干预措施: Abraxane (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: 8 weeks
次要结局
- Objective Response Rate (ORR)(8 weeks)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(8 weeks)
- Overall Survival (OS)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
研究者
Xichun Hu
Vice Director of department of medical oncology
Fudan University
研究点 (1)
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