Clinical Study of Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 414
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This is a multi-center , open-lable clinical trial. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have <1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2. TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease.
The purpose of this study is to assess the efficacy and safety of the following two combinations: i) nab-paclitaxel+carboplatin; ii) nab-paclitaxel+capecitabine in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. Maintenance therapy with capecitabine after completion of combination chemotherapy.
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 to 70 years old;
- •Histologically confirmed triple negative breast cancer;
- •No more than one-line prior treatment for locally advanced or metastatic breast cancer;
- •Have at least one measurable lesion as per the RECIST criteria (version 1.1);
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to one;
- •Patients with life expectancy of at least 3 months;
- •Bone marrow function：neutrophils (≥1.5×10^9/L), platelets (≥100×10^9/L), hemoglobin (≥90 g/L);
- •Renal and hepatic function: Serum creatinine≤ 1.5×institutional upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN; Total bilirubin≤1.5×ULN, or patients with Gilbert's syndrome ≤ 2.5 × ULN;
- •Patients had good compliance with the planned treatment, understood the research process and written informed consent.
排除标准
- •Patients with heart disease above grade II (including grade II) identified by New York Heart Association (NYHA) scores;
- •Brain metastasis;
- •Recurrence or metastasis within 6 months after capecitabine withdrawal;
- •Recurrence or metastasis within 6 months after platinum withdrawal;
- •Progression in the treatment, recurrence or metastasis of paclitaxel (including albumin paclitaxel) within 6 months;
- •Patients required clinical intervention with gastrointestinal bleeding, gastrointestinal obstruction and non-feeding;
- •Patients who had Grade 2 or above Peripheral neuropathy;
- •Patients with severe systemic infection or other serious diseases;
- •Patients allergic to or intolerant of chemotherapeutic drugs or their adjuvants;
- •Patients with other malignant tumors in the past five years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
- •Pregnancy or lactation, as well as reproductive age patients who refused to take appropriate contraceptive measures in the trial;
- •Participation in any trial drug treatment or another interventional clinical trial 30 days before first dose was given;
- •The researchers considered the patients who were not suitable for enrollment.
研究组 & 干预措施
Nab-paclitaxel + Carboplatin
Nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles； Maintenance therapy: Capecitabine 1000 mg/m^2 bid, d1-14; every 21 days, until disease progression or intolerable toxicity;
干预措施: Nab-paclitaxel + Carboplatin (Drug)
Nab-paclitaxel + Capecitabine
Nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and capecitabine given IV at 1000 mg/m^2 bid, d1-14 every 21 days x 6 cycles； Maintenance therapy: Capecitabine 1000 mg/m^2 bid, d1-14; every 21 days, until disease progression or intolerable toxicity;
干预措施: Nab-paclitaxel + Capecitabine (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: 3 years
Up to disease progression or death due to any cause
次要结局
- PFS rate for 6 cycles(At the end of Cycle 6 (each cycle is 21 days))
- Objective response rate (ORR)(3 years)
- Overall survival (OS)(3 years)
- Adverse events (AE)(3 years)
研究者
Cuizhi GENG
Principal Investigator
Hebei Medical University Fourth Hospital