EUCTR2006-006507-36-BE进行中（未招募）1 期
A PHASE III, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED TRIAL EVALUATINGTHE EFFICACY AND SAFETY OF BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPYREGIMENS IN SUBJECTS WITH PREVIOUSLY TREATED METASTATIC BREAST CANCER - Ribbon-2
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 700
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
- •Subjects with a history of brain metastasis are eligible for study participation,
- •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.
- •Subjects 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
- •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 (>5 × the ULN in subjects with known liver involvement and >7 x the ULN in subjects with known bone involvement)
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研究者
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