Avastin® Randomised Trial with neo-adjuvant chemotherapy for patients with early breast cancer
| ISRCTN | ISRCTN68502941 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68502941 |
| EudraCT/CTIS number | 2008-002322-11 |
| ClinicalTrials.gov number | NCT01093235 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/02/2009
- Registration date
- 17/03/2009
- Last edited
- 26/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Dr Helena Earl
Scientific
Scientific
Addenbrookes Hospital
Oncology Department, Box 193
Cambridge
CB2 0QQ
United Kingdom
Study information
| Study design | Randomised (1:1) multicentre phase III prospective open-label trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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 |
| Study acronym | ARTemis |
| Study hypothesis | A short course of pre-operative bevacizumab (Avastin®) in combination with chemotherapy will improve the pathological complete response to neoadjuvant treatment for HER2-negative breast cancer patients, and thereby improve their chances of breast conservation, as well as improving disease-free and overall survival. |
| Ethics approval(s) | South East Research Ethics Committee (REC), 19/11/2008, ref: 08/H1102/104 |
| Condition | Early breast cancer |
| Intervention | Arm A: Docetaxel (D) 100 mg/m^2 intravenous (IV) x 3 cycles every 3 weeks (q3w) followed by 5-fluorouracil 500 mg/m^2 IV, epirubicin 100 mg/m^2 IV and cyclophosphamide 500 mg/m^2 (FEC) on day 1 x 3 cycles q3w Arm B: Docetaxel (D) 100 mg/m^2 IV x 3 cycles every 3 weeks [q3w] and bevacizumab (Avastin®) 15 mg/kg q3w x 3 cycles followed by FEC plus bevacizumab 15 mg/kg x 1 cycle and three weeks later FEC x 2 cycles q3w Duration of treatments is 18 weeks. Duration of follow-up is 5 years. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Bevacizumab (Avastin®), docetaxel, 5-fluorouracil, epirubicin, cyclophosphamide |
| Primary outcome measure | 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 | 1. Disease-free survival, to be measured through follow-up 2. Overall survival, to be measured through follow-up 3. PathCR rate in breast alone, to be measured at surgery 4. Radiological response after 3 and after 6 cycles of chemotherapy 5. Rate of breast conservation, to be measured at surgery 6. Toxicities including in particular cardiac safety and surgical complications (wound healing, bleeding, and thrombosis), to be measured during treatment and follow-up |
| Overall study start date | 01/03/2009 |
| Overall study end date | 31/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 800 |
| Total final enrolment | 800 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/04/2009 |
| Recruitment end date | 31/01/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Addenbrookes Hospital
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
United Kingdom
Sponsor information
Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom
| Website | http://www.cuh.org.uk/research/research_index.html |
|---|---|
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Industry
Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC)
No information available
Roche (UK)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche & Co, F. Hoffmann-La Roche AG, Roche Holding AG, Roche Holding Ltd, Roche Holding, Roche Holding A.G., Roche Holding, Limited, F. Hoffmann-La Roche & Co.
- Location
- Switzerland
Sanofi-Aventis (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2015 | Yes | No | |
| Plain English results | 26/10/2022 | No | Yes | ||
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
