Phase III Study of Adjuvant Capecitabine Metronomic Chemotherapy in Triple-negative Operable Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 443
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
The primary objective of this study is to compare disease-free survival (DFS) of patients with triple negative breast cancer randomised to treatment with standard adjuvant chemotherapy alone or to standard adjuvant chemotherapy followed by 1 year of Capecitabine (Xeloda) metronomic therapy.
详细描述
Triple negative breast cancer (TNBC) is an aggressive disease without tumor-specific treatment options. Patients with triple-negative disease had an increased likelihood of distant recurrence and death within 5 years of diagnosis. Median time to distant recurrence was significantly shorter. This study will evaluate the efficacy and safety of the addition of Capecitabine to standard adjuvant therapy in patients with triple negative breast cancer. Patients will be randomized to receive either standard chemotherapy (according to NCCN guideline), or standard chemotherapy followed by 1 year of metronomic Capecitabine (650mg/m2, twice every day). The anticipated time on study treatment is 12 months, and the target sample size is 432 individuals.Disease-free Survival (DFS) will be primary end point.
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
- •Patients must be >=18 years of age;
- •The patients must be Operable primary invasive breast cancer;
- •Definitive loco-regional surgery must be completed;
- •Primary tumor centrally confirmed as triple negative;
- •Operable node-positive (or node-negative with tumor diameter ≥ 0.5cm);
- •Chest, abdominal, bone imaging performed with 3 months prior to randomization must not reveal the presence of distant spread;
- •There are normal organ function, including bone marrow function, renal function, liver function, and cardiac function;
- •All patients must have signed and dated an informed consent form.
排除标准
- •Patients with bilateral breast cancer, inflammatory carcinomas;
- •Patients with positive supraclavicular or internal mammary lymph node;
- •Previous breast cancer history;
- •Any previous malignancy exceptions for carcinoma of the cervix, squamous carcinoma of the skin, or basal cell carcinoma of the skin;
- •Pregnant or breast-feeding women;
- •Women who are unwilling to agree to use an effective non-hormonal method of contraception during the treatment period of Xeloda;
- •Any sex hormonal therapy;
- •Malabsorption syndrome.
研究组 & 干预措施
Capecitabine
Capecitabine 650 mg/m2 bid
干预措施: Capecitabine (Drug)
结局指标
主要结局
disease-free survival
时间窗: 36 months
The final analysis are expected to occur 36 months after the end of recruitment.
次要结局
未报告次要终点
研究者
Zhong-yu Yuan
MD
Sun Yat-sen University