ISRCTN68502941已完成3 期
A randomised multicentre phase III prospective open-label trial of pre-operative bevacizumab (Avastin®) in combination with neo-adjuvant chemotherapy for early breast cancer patients
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 800
研究概览
简要总结
2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25975632 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients (aged 18 to 70 years [no age limit but must be fit enough to received chemotherapy], either sex) with histologically confirmed HER2-negative invasive breast cancer (either IHC 0/1 or IHC 2+ and fluorescence in situ hybridisation [FISH] negative)
- •2. T2 tumours and above (maximum tumour diameter greater than or equal to 20 mm from an ultrasound) and T4 tumours (including inflammatory breast cancer). For multi-focal tumours, the sum of each tumour's maximum diameter must be greater than or equal to 20 mm, and will be designated 'total tumour size'.
- •3. Any T stage with large axillary nodes (greater than 20 mm) and/or fixed axillary nodes (clinical N2)
- •4. Suitable for neoadjuvant chemotherapy in the opinion of the responsible clinician
排除标准
- •1. HER2 positive invasive cancer (IHC 3+ or FISH positive)
- •2. Uni-focal T0 and T1 tumours with no fixed axillary node or no node greater than or equal to 20 mm (multifocal tumours where the total tumour size [sum of maximum diameter of each lesion] is greater than or equal to 20 mm can be included - see above)
- •3. Patient not suitable for neoadjuvant chemotherapy in opinion of responsible clinician
- •4. Evidence of metastatic disease
- •5. Prior endocrine therapy
- •6. Prior history of breast cancer
- •7. Prior diagnosis of ischaemic heart disease, cerebrovascular disease, peripheral vascular disease, arterial or venous thrombo-embolic disease, cardiac failure, inflammatory bowel disease, gastro-duodenal ulcer, symptomatic diverticulitis, or bleeding diathesis
- •8. Uncontrolled hypertension
研究者
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