NCT00191373已完成2 期
Phase II Study of Gemcitabine and Trastuzumab Therapy in Patients With HER2 Overexpressing Metastatic 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
- 66
- 试验地点
- 14
- 主要终点
- - Overall response rates
研究概览
简要总结
This phase II trial that includes Gemcitabine 1,250mg/m2 to be administered over approximately 30 minutes on days 1 and 8, every 21 days and Trastuzumab 8 mg/kg IV to be administered over 90 minutes on day 1 of the first cycle, then 6mg/kg as a 30 minute infusion administered on subsequent cycles.
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
- •Patients must have histologically or cytologically confirmed invasive breast cancer, with stage IV disease
- •Tumors tested by IHC must be 3+ positive for HER2 overexpression. Tumors tested by FISH must be positive by the specific FISH assay for genetic amplification of HER
- •Tumors that are 3+ by IHC but negative by FISH assay are ineligible
- •Patients must have measurable disease
- •Patients may NOT have received prior chemotherapy or prior trastuzumab therapy for metastatic breast cancer.
- •Patients may have received prior chemotherapy and/or hormonal therapy for early stage breast cancer, including taxane-based chemotherapy regimens. Patients may NOT have received trastuzumab in the adjuvant setting unless disease free interval from completion of trastuzumab to time of relapse is greater than 12 months.
排除标准
- •Patients who have had prior gemcitabine chemotherapy and adjuvant trastuzumab and had less than 12- month disease free interval
- •Patients with known leptomeningeal carcinomatosis
结局指标
主要结局
- Overall response rates
次要结局
- Time to disease progression,Time to treatment failure, Overall survival, Toxicity of the combination
研究者
研究点 (14)
Loading locations...
相似试验
已完成
1 期
Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast CancerBreast CancerNCT02139358H. Lee Moffitt Cancer Center and Research Institute15
已完成
2 期
A Trial of Gemcitabine Combined With Vinorelbine as First Line Chemotherapy for Metastatic Breast CancerBreast CancerNCT00192062Eli Lilly and Company80
已完成
2 期
Fixed Dose Rate Gemcitabine and Cisplatin Followed by Chemoradiation for Locally Advanced Pancreatic CancerPancreatic CancerNCT01396668Seoul National University Hospital35
已完成
2 期
Panitumumab, Gemcitabine and Carboplatin in Triple-Negative Metastatic Breast CancerMetastatic Breast CancerNCT00894504SCRI Development Innovations, LLC71
已完成
2 期
Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial CancerEndometrial AdenocarcinomaEndometrial Adenosquamous CarcinomaEndometrial Clear Cell AdenocarcinomaRecurrent Uterine Corpus CarcinomaNCT00820898Gynecologic Oncology Group24