An Open-label, Single-arm, Multicenter, Phase II Study to Assess the Efficacy and Safety of Aiyi® (Tegafur Gimeracil Oteracil Potassium Capsule) as 2nd Line Treatment in Patients With Advanced Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Progression-free survival
研究概览
简要总结
The purpose of this study is to assess the effectiveness and safety profile of Aiyi®(Tegafur Gimeracil Oteracil Potassium Capsule, TS-1) as a second line therapy in Chinese female patients with advanced metastatic breast cancer.
详细描述
Tegafur Gimeracil Oteracil Potassium Capsule is a novel oral derivative of the 5-fluorouracil(5-FU) prodrug tegafur combined with two modulators. Recent clinical trial has reported the promising effect of Tegafur Gimeracil Oteracil Potassium Capsule in metastatic breast cancer. The innovative drug, S-1, has obtained the approval of treatment of advanced breast cancer in Japan, meanwhile, Generic drug is only approved for the indication of gastric cancer in China mainland by Chinese authority, SFDA, and no Chinese clinical study data of TS-1 in breast cancer so far.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years old female.
- •ECOG status: 0-
- •Life expectancy of ≥ 3 months.
- •Histologic or cytologic diagnosis of breast cancer.
- •Progression after receiving one standard prior chemotherapy regimen for recurrent or metastatic lesion except an endocrine regimen.
- •At least one measurable lesion of >=2 cm (>=1 cm on spiral CT scan)according to RECIST (v1.1).
- •Adequate organ functions:
- •Hematopoietic: Hemoglobin ≥90g/L, Absolute neutrophil count ≥1.5×10^9/L, Platelet count ≥80×10^9/L.
- •Biochemistry: TBil ≤1.5 times upper limit of normal (ULN), AST and ALT ≤2.5× ULN(≤5x ULN if due to liver metastases), Creatinine ≤1.0×ULN and Creatinine clearance >50 ml/min.
- •Women with children potential must have negative pregnancy tests 7 days prior to enrollment and be willing to practice acceptable methods of birth control during the study and 8 weeks after last drug administered.
- •Ability to take oral medication .
- •Signed informed consent.
排除标准
- •Pregnancy or lactation or no effective contraception in fertile patients.
- •Prior treatment with 5-FU or drugs of same class(excluding patients that relapsed more than one year after adjuvant therapy).
- •Less than 4 weeks since prior investigational agents.
- •conditions impacting oral drug taking or absorption (e.g. inability to swallow, gastrointestinal resection, chronic diarrhea, intestinal obstruction).
- •Organ invasion with rapid progression(e.g. lesions exceeding half of Liver or Lung).
- •CNS or psychiatric disorders.
- •Allergic to 5-FU.
- •Only with bone metastases and no measurable lesions.
- •Clinically significant heart diseases (e.g.congestive heart failure, ventricular arrhythmia, myocardial infarction) before enrollment.
- •Serious peptic ulcer disease or digestive disorders.
- •Bone marrow (Hemoglobin <90g/dl, ANC <1.5×10^9/L, Platelet count <75×10^9/L).
- •Renal function disorder (Creatinine >1.0×ULN).
- •Liver function disorder (TBil >1.5×ULN).
- •Uncontrolled brain metastases.
- •Noncompliance with the study protocol.
研究组 & 干预措施
Aiyi®
Tegafur Gimeracil Oteracil Potassium Capsule
干预措施: Tegafur Gimeracil Oteracil Potassium Capsule (Drug)
结局指标
主要结局
Progression-free survival
时间窗: Up to 2 years
次要结局
- Clinical response rate(Every six weeks)
- Adverse events(Subjects will be followed from date of enrollment until the date of last visit, anticipated up to 2 years)
研究者
Binghe Xu
Deputy Director of Department of Medical Oncology
Chinese Academy of Medical Sciences