EUCTR2008-006872-31-FR进行中（未招募）1 期
A randomized phase III clinical study of bevacizumab plus capecitabine vs. bevacizumab alone as maintenance therapy in patients with HER2-negative metastatic breast cancer that has not progressed during first-line docetaxel plus bevacizumab therapy. - IMELDA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 287
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Initial treatment phase:
- •1. Female patients aged = 18 years
- •2. Patients with histologically confirmed and documented, HER2-negative metastatic adenocarcinoma of the breast, who are candidates for taxane-based chemotherapy
- •3. Documented ER/PgR status
- •4. ECOG PS of 0-1;
- •5. Life expectancy of = 12 weeks
- •Maintenance treatment phase:
- •1. Patients must have SD, PR or CR per RECIST by the end of the initial treatment phase with bevacizumab plus docetaxel. Those patients who meet the response criteria at cycle 6 can be immediately randomised into the maintenance treatment phase
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Previous chemotherapy for mBC. Prior hormone therapy for metastatic disease is allowed.
- •2. Prior adjuvant/neoadjuvant chemotherapy within 6 m. prior to first study treatment administration.
- •3. Prior adjuvant/neoadjuvant anthracycline-based chemotherapy with a max. cumulative dose >360 mg/m2 for doxorubicin or >720 mg/m2 for epirubicin.
- •4. Prior radiotherapy for the treatment of metastatic disease. Radiotherapy administered for the relief of metastatic bone pain is allowed prior to study entry, as long as no more than 30% of marrow-bearing bone was irradiated.
- •5. Chronic daily treatment with aspirin (>325 mg/day) or clopidogrel (>75 mg/day).
- •6. Inadequate bone marrow function
- •7. Inadequate liver function
- •8. Inadequate renal function
- •9. Pregnant or lactating females.
- •10. Women of childbearing potential not using effective, non-hormonal means of contraception.
- •11. Major surgical procedure within 28 days prior to the first study treatment, or anticipation of the need for major surgery during the course of the study treatment.
- •12. Minor surgical procedures, within 24 hours prior to the first study treatment.
- •13. History of uncontrolled seizures, CNS disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
- •14. Pre-existing peripheral neuropathy >CTC grade 2.
- •15. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
- •16. Uncontrolled hypertension (systolic >150 mm Hg and/or diastolic >100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident (CVA)/stroke within =6 months prior to the first study treatment, myocardial infarction within =6 months prior to the first study treatment, unstable angina, NYHA grade II or greater CHF, or serious cardiac arrhythmia requiring medication.
- •17. History of abdominal fistula, grade 4 bowel obstruction or gastrointestinal perforation, intra-abdominal abscess within 6 months prior to randomisation.
- •18. Lack of physical integrity of the upper gastrointestinal tract, clinically significant malabsorption syndrome, or inability to take oral medications.
- •19. Serious non-healing wound, peptic ulcer or bone fracture.
- •20. Serious active infection requiring i.v. antibiotics at enrolment.
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