ISRCTN68502941
Completed
Phase 3
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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Early breast cancer
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust (UK)
- Enrollment
- 800
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25975632 results
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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