NCT04517292Unknown2 期
A Phase II, Single-center, Randomized Study of Eribulin Plus Cisplatin (EP) Versus Gemcitabine Plus Cisplatin (GP) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
Eribulin Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)
详细描述
A Phase II, Single-center, Randomized Study of Eribulin Plus Cisplatin (EP) Versus Gemcitabine Plus Cisplatin (GP) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Females with age between 18 and 70 years old
- •Histological proven unresectable recurrent or advanced breast cancer, including de novo stage IV disease.
- •Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by immunohistochemistry (ER <1%, PR <1% and Her2 negative). A negative Her2 gene amplification should be verified by FISH test for those patients with Her2 (2+). For those with Her2 (1+), FISH test might be considered by the investigator.
- •No prior chemotherapy for metastatic breast cancer is permitted. Prior administration of chemotherapy in the adjuvant/neoadjuvant setting is acceptable if completed 6 months before the enrollment.
- •At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
- •Performance status no more than 1
- •All patients enrolled are required to have adequate hematologic, hepatic, and renal function
- •Life expectancy longer than 12 weeks
- •No serious medical history of heart, lung, liver and kidney
- •Be able to understand the study procedures and sign informed consent.
- •Patients with good compliance.
排除标准
- •Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days before the first day of drug dosing, or, if positive, a pregnancy should be ruled out by ultrasound)
- •Women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
- •Treatment with radiotherapy at the axial skeleton within 4 weeks before the first treatment or has not recovered from all toxicities of previous radiotherapy
- •Treatment with an investigational product within 4 weeks before the first treatment
- •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 the registration
- •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 having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
- •Uncontrolled serious infection
研究组 & 干预措施
Gemcitabine,cisplatin
Active Comparator
GP (gemcitabine and cisplatin combination)
干预措施: Gemcitabine,cisplatin (Drug)
Eribulin,cisplatin
Experimental
EP (Eribulin and cisplatin combination)
干预措施: Eribulin,cisplatin (Drug)
结局指标
主要结局
PFS
时间窗: approximately 6 weeks
Progression Free Survival
次要结局
- ORR(approximately 6 weeks)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(approximately 18 weeks)
- 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
Jian Zhang,MD
Associate chief physician
Fudan University
研究点 (1)
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