Avastin® Randomised Trial with neo-adjuvant chemotherapy for patients with early breast cancer

Phase 3

Completed

• Conditions: Early breast cancer; Cancer; Malignant neoplasm of the breast

• Registration Number: ISRCTN68502941
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust (UK)

Brief Summary

2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25975632 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-17
• Study Completion: 2013-01-31
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete pathological response (pathCR) rates (tumour and lymph nodes) after neoadjuvant chemotherapy defined as no residual invasive carcinoma within the breast (ductal carcinoma in situ [DCIS] permitted) and no evidence of metastatic disease within the lymph nodes, to be measured at surgery.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Disease-free survival, to be measured through follow-up<br> 2. Overall survival, to be measured through follow-up<br> 3. PathCR rate in breast alone, to be measured at surgery<br> 4. Radiological response after 3 and after 6 cycles of chemotherapy<br> 5. Rate of breast conservation, to be measured at surgery<br> 6. Toxicities including in particular cardiac safety and surgical complications (wound healing, bleeding, and thrombosis), to be measured during treatment and follow-up<br>