NCT00868634已完成3 期
Capecitabine and Bevacizumab ± Vinorelbine as 1st Line Treatment in HER-2 Negative Metastatic or Locally Advanced Inoperable Breast Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- iOMEDICO AG
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
The aim of the trial is to detect the superiority of the triple combination of capecitabine, bevacizumab and vinorelbine versus the combination of capecitabine and bevacizumab in patients with metastatic breast cancer. 600 patients, 300 in each treatment group, are treated until progression of disease to determine PFS.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Able to comply with the protocol.
- •ECOG Performance status 0 -
- •Life expectancy more than 12 weeks.
- •Known ER / PR status.
- •Confirmed HER2/neu-negative, adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy.
- •Previous (neo)adjuvant chemotherapy is allowed provided that the last dose of chemotherapy was applied more than 6 months prior to randomization.
- •Previous adjuvant radiotherapy is allowed as part of the treatment of early breast cancer provided that no more than 30% of marrow-bearing bone was irradiated.
- •No signs and symptoms of CHF.
- •Adequate hepatic and renal function values.
- •Adequate hematologic function values.
排除标准
- •Pregnant or lactating females.
- •Previous chemotherapy for metastatic or locally recurrent breast cancer.
- •Previous radiotherapy for the treatment of metastatic disease (unless given for the relief of metastatic bone pain)
- •Evidence of spinal cord compression or current evidence of central nervous system (CNS) metastases.
- •Major surgical procedure, open biopsy or significant traumatic in-jury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study treatment.
- •History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
- •Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg). Clinically significant (i.e. active) cardiovascular disease, requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication.
- •Non-healing wound, active peptic ulcer or bone fracture.
- •History of abdominal fistula, or any grade 4 nongastrointestinal fistula, gastrointestinal perforation or intrabdominal abscess within 6 months of randomization.
- •Active infection requiring i.v. antibiotics at randomization.
- •Clinically significant malabsorption syndrome or inability to take oral medication.
- •Known hypersensitivity to any of the study drugs or excipients.
- •Concurrent treatment with any drug interfering with study medication. Concurrent participation in another clinical trial. Prior participation is allowed when the last study medication was applied more than 4 weeks prior to randomization.
研究组 & 干预措施
A
Active Comparator
Capecitabine / Bevacizumab
干预措施: capecitabine (Drug)
A
Active Comparator
Capecitabine / Bevacizumab
干预措施: bevacizumab (Drug)
B
Experimental
Capecitabine / Bevacizumab / Vinorelbine
干预措施: capecitabine (Drug)
B
Experimental
Capecitabine / Bevacizumab / Vinorelbine
干预措施: bevacizumab (Drug)
B
Experimental
Capecitabine / Bevacizumab / Vinorelbine
干预措施: vinorelbine (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: end of trial
次要结局
- adverse events and serious adverse events(during the whole time of treatment)
- Overall Response Rate (ORR = CR +PR)(end of trial)
- Overall Survival (OS)(end of trial)
研究者
研究点 (1)
Loading locations...
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