S1 Plus Docetaxel Versus Capecitabine Plus Docetaxel First-line Treatment in Patients With Advanced Breast Cancer: a Phase 2, Prospective,Multicenter, Randomised Study
试验速览
- 阶段
- 2 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
To compare the progression free survival(PFS) and safety of TS-S vs. TX-X in Patients With Advanced Breast Cancer first-line treatment
详细描述
To compare progression free survival (PFS) of the S-1 combined with docetaxel followed by maintenance treatment with S-1 and capecitabine combined with docetaxel followed by maintenance therapy with capecitabine in patients with advanced breast cancer first-line treatment.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 ≤ age ≤ 75;
- •ECOG 0-2, The expected survival time more than 3 months;
- •Histologically or cytologically proven locally advanced or advanced HER-2 negative breast cancer;
- •No chemical treatment after Cancer recurrence;
- •At least one measurable disease ( as per RECIST1.1);
- •Adequate bone marrow functions (ANC ≥1.5×109 /L, PLT ≥100×109 /L, HB ≥90 g/L);
- •Adequate renal functions(serum creatinine ≤ 1.5 ULN; creatinine clearance≥50 ml/min);
- •liver functions (serum bilirubin ≤ 1.5ULN, AST/ALT ≤ 2.5 ULN);
- •Written informed consent;
- •Pregnancy test (serum or urine) within 7 days of entry and willing to use the appropriate method of contraception.
排除标准
- •Previously chemotherapy with cytotoxic drugs
- •Pregnant, lactating women Did not take effective contraceptive measures
- •Adjuvant chemotherapy/ neoadjuvant chemotherapy with 5-FU-based chemotherapy or Paclitaxel -based chemotherapy within 1 year after recurrence;
- •Her-2 positive or unknown
- •Other trails Before 4weeks
- •Affection of the absorption of drugs(Unable to swallow、after gastrectomy、Chronic diarrhea and intestinal obstruction
- •Organs with rapid progression of invasion(Liver and lung lesions more than 1/2 organ area or hepatic insufficiency)
- •Central nervous system disorders or mental disorders
- •For docetaxel or fluorouracil or Twain 80 had serious adverse reactions or Allergy to 5-FU
- •Severe upper gastrointestinal ulcer or absorption dysfunction syndrome
- •Abnormal blood routine (ANC <1.5×109 /L, PLT <100×109 /L, HB <90 g/L);
- •Renal functions(serum creatinine > 1.5 ULN);
- •Liver functions (serum bilirubin > 1.5ULN
- •Brain metastases out of control
- •Other unapplicable
研究组 & 干预措施
test group
S1 plus Docetaxel ：S-1 80mg to 120 mg per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1
干预措施: S1 plus Docetaxel (Drug)
control group
Capecitabine plus Docetaxel ：Capecitabine 1,000 mg/m2 per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1
干预措施: Capecitabine plus Docetaxel (Drug)
结局指标
主要结局
progression free survival
时间窗: 2 years
次要结局
- objective response rate(2 years)
- overall survival(1 year)
- Disease control rate(2 years)
研究者
Binghe Xu
Professor and Director, Department of Medical Oncology
Cancer Institute and Hospital, Chinese Academy of Medical Sciences