Condition category
Cancer
Date applied
03/02/2009
Date assigned
17/03/2009
Last edited
18/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Helena Earl

ORCID ID

Contact details

Addenbrookes Hospital
Oncology Department
Box 193
Cambridge
CB2 0QQ
United Kingdom

Additional identifiers

EudraCT number

2008-002322-11

ClinicalTrials.gov number

NCT01093235

Protocol/serial number

N/A

Study information

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

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

South East Research Ethics Committee (REC), 19/11/2008, ref: 08/H1102/104

Study design

Randomised (1:1) multicentre phase III prospective open-label trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Phase III

Drug names

Bevacizumab (Avastin®), docetaxel, 5-fluorouracil, epirubicin, cyclophosphamide

Primary outcome measures

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 trial start date

01/03/2009

Overall trial end date

31/01/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

800

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

United Kingdom

Trial participating centre

Addenbrookes Hospital
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

Government

Website

http://www.cuh.org.uk/research/research_index.html

Funders

Funder type

Industry

Funder name

Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Roche (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Switzerland

Funder name

Sanofi-Aventis (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

Additional files

Editorial Notes