Study of Trastuzumab Combined With Capecitabine on HER2-positive Metastatic Breast Cancer Patients Pretreated With Trastuzumab and Taxanes or HER2- Positive Breast Cancer Patients Relapsed From (Neo)Adjuvant Therapy of Trastuzumab and Taxanes
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 主要终点
- Percentage of Participants With Overall Response
研究概览
简要总结
This single arm. open-label study will assess the efficacy and safety of Herceptin (trastuzumab) in combination with Xeloda (capecitabine) in patients with metastatic or recurrent HER2-positive breast cancer, refractory to or relapsing after chemotherapy with Herceptin and taxanes. Patients will receive Xeloda 900mg/m2 twice daily orally on days 1-14 of each 3-week cycle and Herceptin 8mg/kg intravenously (iv) on day 1 of the first cycle followed by 6mg/kg iv every 3 weeks. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients, 18-65 years of age
- •Histologically confirmed HER2-positive breast cancer with measurable lesions (according to RECIST criteria)
- •Metastatic disease after first-line therapy or recurrent disease after (neo)adjuvant therapy with Herceptin and taxanes
- •ECOG performance status 0-2
排除标准
- •CNS metastases which are not well controlled
- •Simultaneous treatment with sorivudine
- •History of another malignancy within the last 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in-situ of the uterine cervix
- •Pregnant or lactating women
研究组 & 干预措施
Single Arm
干预措施: capecitabine [Xeloda] (Drug)
Single Arm
干预措施: trastuzumab [Herceptin] (Drug)
结局指标
主要结局
Percentage of Participants With Overall Response
时间窗: Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death
The tumor response was measured according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1).
次要结局
- Time to Disease Progression(Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death)
- Overall Survival(Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death)
- Progression-Free Survival(Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death)