Randomised Phase II Study of the Combination of Oral Vinorelbine With Capecitabine Versus Gemcitabine in Combination With Paclitaxel Versus Gemcitabine in Combination With Docetaxel as First Line Chemotherapy in Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 152
- 主要终点
- Disease Control Rate (DCR)
研究概览
简要总结
The aim of this international open-label randomized phase II trial is to evaluate the efficacy and safety of an all-oral combination and two all-intravenous combinations as first-line therapy for HER2-negative mBC patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the breast;
- •Documented metastatic disease previously untreated by chemotherapy;
- •HER2 negative (assessed by 0-1+ IHC or 2+ IHC with FISH-) on the primary tumor or on metastatic site;
- •Karnofsky Performance Status 70%.
排除标准
- •Local relapse alone after conservative treatment or contra-lateral tumor;
- •Patients with symptoms suggesting CNS involvement or leptomeningeal metastases;
- •Concomitant hormonal therapy for metastatic breast cancer;
- •Prior chemotherapy in the metastatic setting;
- •Patients previously treated with a vinca-alkaloid, capecitabine, gemcitabine or taxanes;
- •Prior severe and unexpected reaction to fluoropyrimidine therapy (with or without documented DPD deficiency) or known hypersensitivity to 5-fluorouracil.
研究组 & 干预措施
Vinorelbine-Capecitabine (arm A)
oral vinorelbine (OV) with capecitabine (CAP)
干预措施: oral vinorelbine (Drug)
Vinorelbine-Capecitabine (arm A)
oral vinorelbine (OV) with capecitabine (CAP)
干预措施: Capecitabine (Drug)
Gemcitabine-Paclitaxel (arm B)
gemcitabine (GEM) in combination with paclitaxel (PAC)
干预措施: Gemcitabine 1250 mg/m² (Drug)
Gemcitabine-Paclitaxel (arm B)
gemcitabine (GEM) in combination with paclitaxel (PAC)
干预措施: Paclitaxel (Drug)
Gemcitabine-Docetaxel (arm C)
gemcitabine (GEM) in combination with docetaxel (DOC)
干预措施: Gemcitabine 1000 mg/m² (Drug)
Gemcitabine-Docetaxel (arm C)
gemcitabine (GEM) in combination with docetaxel (DOC)
干预措施: Docetaxel (Drug)
结局指标
主要结局
Disease Control Rate (DCR)
时间窗: From Baseline to disease progression or death, up to 6 years
Disease control rate (DCR) defined as the sum of complete response, partial response and stable disease for at least 3 months according to RECIST criteria version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR)= Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Stable disease: no partial response or progression of the disease
次要结局
未报告次要终点