EUCTR2006-006507-36-LV进行中（未招募）不适用
A PHASE III, MULTICENTER, RANDOMIZED,PLACEBO-CONTROLLED TRIAL EVALUATINGTHE EFFICACY AND SAFETY OF BEVACIZUMABIN COMBINATION WITH CHEMOTHERAPYREGIMENS IN SUBJECTS WITH PREVIOUSLYTREATED METASTATIC BREAST CANCER - Ribbon-2
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 386
研究概览
简要总结
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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
- •Subjects must meet the following criteria to be eligible for study entry:
- •Signed Informed Consent Form
- •= 18 years of age
- •Histologically confirmed carcinoma of the breast with measurable or
- •non-measurable metastatic disease that has progressed Patients with a history of brain metastasis are eligible for study participation (U.S. only), as long as their brain metastases have been treated and they have no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT scans) during the screening period. CT scan with contrast or MRI scan of the brain must be performed at least 3 weeks after completion of all therapy to the brain.
- •Treatment for brain metastasis may include the following: WBRT, SRS
- •(Gamma knife, LINAC, or equivalent), or a combination as deemed appropriate by
- •the treating physician. Radiotherapy and stereotactic radiosurgery must be
- •completed at least 4 weeks prior to Day 0.
- •Patients may also have neurosurgical resection. Neurosurgery must be completed
- •at least 6 weeks prior to Day 0, and brain biopsy must be completed at least
- •4 weeks prior to Day 0.
- •Progression of disease during or following administration of one
- •(non-investigational) chemotherapy regimen, defined as single-agent
- •chemotherapy administered prior to or during disease progression or a
- •pre-specified combination or sequence of cytotoxic agents administered in the
- •first-line setting
- •Subjects whose initial treatment changed prior to progression in the
- •first-line setting are ineligible unless the change occurred within 30 days
- •of initial treatment due to toxicity.
- •ECOG performance status of 0 or 1 (see Appendix B)
- •For women of childbearing potential, use of an effective means of
- •non-hormonal contraception
- •Life expectancy = 3 months
- •Willingness and capacity to comply with study and follow-up proceduresfirst-line setting are ineligible unless the change occurred within 30 days
- •of initial treatment due to toxicity.
- •ECOG performance status of 0 or 1 (see Appendix B)
- •For women of childbearing potential, use of an effective means of
- •non-hormonal contraception
- •Life expectancy = 3 months
- •Willingness and capacity to comply with study and follow-up procedures
- •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
- •Subjects who meet any of the following criteria will be excluded from study entry:
- •a. Disease Treatment History
- •Prior hormonal therapy only as treatment for metastatic disease
- •without chemotherapy. Patients must have received chemotherapy for their
- •metastatic disease in the first-line setting. Hormone therapy alone is not allowed.
- •For subjects who have received prior anthracycline-based therapy,
- •documentation of left ventricular ejection fraction < 50% by either
- •multiple gated acquisition (MUGA) or echocardiogram (ECHO)
- •Treatment with more than one prior cytotoxic regimen for MBC
- •HER2-positive status
- •In general, HER2-positive status will be identified by a fluorescence in situ
- •hybridization (FISH) assay as evaluated at the institution or, if FISH is
- •unavailable, a 2 + or 3 + immunohistochemistry result (but the method of
- •identification may vary by region or institution). Patients who have unknown
- •HER2 status, and for whom determination of HER2 status is not possible,
- •are eligible for this study.
- •Unknown ER and PR status
- •Radiation therapy other than for palliation or brain metastasis, biologic therapy,
- •or chemotherapy for MBC within 21 days prior to Day 0
- •Prior therapy with bevacizumab or other VEGF pathway–targeted therapy
- •b. Bevacizumab Exclusion Criteria
- •Untreated brain metastasis
- •Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg on anti-hypertensive medications
- •Unstable angina
- •New York Heart Association Grade II or greater CHF (see Appendix C)
- •History of myocardial infarction within 6 months prior to Day 0 (the day of the
- •first bevacizumab/placebo infusion)
- •History of stroke or transient ischemic attack within 6 months prior to Day 0
- •Clinically significant peripheral vascular disease
- •Evidence of bleeding diathesis or coagulopathy
- •Major surgical procedure, open biopsy, or significant traumatic injury within
- •28 days prior to Day 0; anticipation of need for major elective surgical
- •procedure during the study
- •Minor surgical procedures, fine-needle aspirations, or core biopsies within
- •7 days prior to Day 0
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
- •abscess within 6 months prior to Day 0
- •Serious, non-healing wound, ulcer, or bone fracture
- •Subjects with fractures secondary to metastatic disease are eligible after
- •appropriate radiotherapy.
- •History of anaphylactic reaction to monoclonal antibody therapy not controlled with
- •treatment premedication
- •c. General Exclusion Criteria
- •Inadequate organ function, as evidenced by any of the following laboratory
- •Absolute neutrophil count < 1500/µL
- •Platelet count < 100,000/µL
- •Total bilirubin > 1.5 mg/dL
- •AST and/or ALT > 2 × the upper limit of normal (ULN) ( > 5 × the ULN in
- •subjects with known liver involvement)
- •Alkaline phosphatase >2 × the ULN (>7 × the ULN in subjects with known
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