NCT00601159已完成2 期
Phase Ⅱ Study of Gemcitabine and Cisplatin as First Line Combination Therapy in Patients With Triple-negative MBC
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
- 70
- 试验地点
- 1
- 主要终点
- PFS (progression free survival)
研究概览
简要总结
Primary objective of this study is to evaluate the efficacy of gemcitabine and cisplatin as first line therapy in patients with triple-negative MBC. 80 patients will be treated into this study.
详细描述
Triple-negative breast tumors could contribute to the poor prognosis comparing with luminal A breast cancer.Fewer study has revealed that Cisplatin-based therapy may be effective for this type breast cancer.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Give written informed consent prior to study, with understanding that the patient has the right to withdraw from the study at any time without prejudice
- •Be female and ≥18 and ≤75 years of age
- •Be ambulatory and have ECOG performance stastus of ≤1
- •Have histological confirmed breast cancer,and the speciman confirmed ER negative,PR negatiev, and HER-2 negative by immunochemistry technich of Fudan cancer hospital.
- •Locally advanced or metastastic breast cancer who didn't receive first-line chemotherapy. No matter whether the patient has received anthracyclin or taxane treatment as neo-adjuvant or adjuvant treatment.
- •Have at least one target lesion according to the RECIST criteria.
- •Exclusion criteria:
- •Preganant or lactating women
- •Advaced patient has received one or more chemotherapies
- •Chemotherapy within four weeks preceding treatment start
- •Radiotherapy to the axial skeleton within the 4 weeks preceding study treatment start or insufficient recovery from the effects of prior radiotherapy
- •Participation in any investigational drug study within 4 weeks preceeding treatment start
- •Evidence of CNS metastasis
- •History of another malignacy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer
- •Abnormal laboratory values: hemoglobin <
- •0g/dl, neutrophil< 1.5×109/L, platelet< 100×109/L.
- •serum creatine > upper limit of normal (ULN)
- •serum bilirubin > ULN
- •ALT and AST >5×ULN
- •AKP >5×ULN
- •Serious uncontrolled intercurrence infection
- •Life expectancy of less than 3 months
排除标准
- 未提供
研究组 & 干预措施
gemcitabine and cisplatin
Experimental
cisplatin and gemcitabine in the management of triple negative metastatic breast cancer
干预措施: gemcitabine and cisplatin (Drug)
结局指标
主要结局
PFS (progression free survival)
时间窗: 1 year
次要结局
- BRCA1 mutation realtionship with efficacy and toxicity analysis(at the end of therapy)
- side effects(6 months)
- pharmacogenetic analysis(collect blood samples before therapy)
研究者
研究点 (1)
Loading locations...
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