EUCTR2011-005335-97-BE进行中（未招募）1 期
A phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of bevacizumab, and associated biomarkers, in combination with paclitaxel compared with paclitaxel plus placebo as first-line treatment of patients with HER2-negative metastatic breast cancer - Meridian
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
- 480
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
- All
入选标准
- •1. Histologically or cytologically confirmed, HER2 negative adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.
- •2. Signed Informed Consent Form
- •3. Age = 18 years
- •4. ECOG performance status of 0 or 1
- •5. Ability and capacity to comply with study and follow up procedures
- •6. For men and women with reproductive potential (women < 2 years
- •after last menstruation and not surgically sterile), use of an acceptable and
- •effective method of non-hormonal contraception (intrauterine contraceptive device or barrier method of contraception in conjunction with spermicidal jelly) during treatment and for at least 6 months after the completion of treatment; use of oral hormonal contraceptives is allowed, however, concurrent use of at least one non-hormonal contraceptive method is mandatory.
- •7. For patients who have received recent radiotherapy, recovery prior to randomization from any significant (Grade = 3) acute toxicity, and radiation treatments have to be completed more than 3 weeks from randomization
- •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 384
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 96
排除标准
- •Disease-Specific Exclusions
- •1. HER2-positive status.
- •2. Prior chemotherapy for locally recurrent or metastatic disease
- •3. Prior hormonal therapy < 2 weeks prior to randomization.
- •4. Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has been for at least 12 months prior to randomization.
- •5. Investigational therapy within 28 days of randomization
- •General Medical Exclusions
- •6. Life expectancy of < 12 weeks
- •7. Inadequate organ function
- •8. Persistent Grade = 3 sensory neuropathy
- •9. Uncontrolled serious medical or psychiatric illness
- •10. Active infection requiring intravenous (IV) antibiotics at screening
- •11. Pregnancy (positive pregnancy test) or lactation.
- •12. Patients with a history of bilateral breast cancer.
- •13. History of other malignancies within 5 years prior to screening, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- •Bevacizumab-Specific Exclusions
- •14. Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
- •15. Prior history of hypertensive crisis or hypertensive encephalopathy
- •16. New York Heart Association Class II or greater, CHF/left ventricular ejection fraction < 55%
- •17. History of myocardial infarction or unstable angina within 6 months prior to randomization
- •18. History of stroke or transient ischemic attack within 6 months prior to randomization
- •19. Known CNS disease except for treated brain metastasis.
- •20. Significant vascular disease
- •21. History of hemoptysis
- •22. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- •23. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization or anticipation of need for major surgical procedure during the course of the study
- •24. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to randomization
- •25. History of abdominal fistula or gastrointestinal (GI) perforation within 6 months prior to randomization
- •26. Serious, non-healing wound, active ulcer, or untreated bone fracture
- •27. Proteinuria at screening
- •28. Known hypersensitivity to any component of bevacizumab
- •29. Prior therapy with bevacizumab, sorafenib, sunitinib, or other
- •VEGF pathway–targeted therapy
- •Paclitaxel-Specific Exclusions
- •30. History of severe hypersensitivity to paclitaxel or to any of the excipients, especially macrogolglycerol ricinoleate
- •31. Paclitaxel should not be administered to patients with baseline neutrophil count <1500/mm3.
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