ARTemis: Avastin® Randomised
Trial with neo-adjuvant
chemotherapy for patients with
early breast cancer
ARTemis Newsletter
Issue 20
September 2014
Welcome to this twentieth edition which will tell you about Success, Data, Translational Sub-Studies,
Staff Changes & Other breast trials.
Success
Following the success of the ARTemis presentation on PathCR at ASCO in June, we are reporting further on ARTemis
data. The CI will be presenting the primary end point results “ARTemis: A randomised trial of bevacizumab with neoadjuvant chemotherapy (NACT) for patients with HER2-negative early breast cancer: primary endpoint - pathological
complete response” at the NCRI cancer conference in Liverpool (2-5 Nov 2014).
A big thank you to everyone who has returned their data queries to meet our deadline, and we hope that the remaining
queries will follow as soon as possible. A particular thank you to the teams at Aberdeen, Addenbrooke’s, Nottingham City,
Peterborough City, Southampton General and Western General Hospitals for their speedy data responses.
Addenbrookes: L-R Dr Luke Hughes-Davies, Dr Elizabeth Cox,
Anne Roberts, Nathan Sugden, Cathy Thorbinson, Dr Jean Abraham,
Katie Poole
Aberdeen
Royal
Infirmary
Nottingham
City
Hospital
Southampton: Jenny
Lowry
Western General: L-R Jennifer Waddell.
Elaine
Murray,
Heather
McVicars,
Paula Little
Peterborough
City
Hospital
Data
Radiology Forms: On completing the Radiology Forms, please ensure that the tumour size columns (S1-S5) are
reported consistently across all three radiology forms, and that tumour bulk = the sum of the longest single diameter of
each measureable breast tumour (ie axillary tumours are not included in the tumour bulk). Ultrasound measurements
taken at both the midway and end of treatment scans must be compared to the pre-treatment (baseline) ultrasound
measurements in order to assess the radiological response. Amendments/new data for the ‘tumour bulk’ and ‘response’
can only be made, and the three radiology forms in the CRF must be signed, by the responsible radiologist (who must
have signed the Site Signature Log) or PI.
Annual Follow-up Form: Please provide details of ‘further chemotherapy’ for patients’ primary breast cancer
(excluding treatment for relapse or new primary) since completion of trial therapy if patients:


withdrew from trial treatment and went on to receive further chemotherapy (adjuvantly or neo-adjuvantly) without
further treatment forms completing,
received further chemotherapy after surgery.
Quality of Life Questionnaires: Don’t forget to include details of radiotherapy and endocrine therapy in the
‘additional cancer therapy’ if the patient received them for their primary breast cancer following completion of ARTemis
trial treatment (excluding treatment for relapse or new primary).
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Data
Please continue to send in these questionnaires for the 12 & 24 month follow-up time points.
Translational Sub-Studies
We have registered 180 patients for the SCARF sub-study. This is fantastic in such a short space of time so thank you to
all those sites who have registered.
Please do not offer your patient PART 6B (relapse) unless they have already relapsed, or do relapse in the future. On the
SCARF registration form for PART 6A it is fine to add ‘n/a’ to the consent questions relating to Part 6B and submit a
second registration form if a subsequent relapse occurs.
Please don’t forget to send in samples for SCARF, Follow-up and Relapse.
For pathology slides and block requests please assist your pathology departments in sending these in asap e.g. providing
them with consent forms or patient data as needed.
Staff Changes
Asha is off to pastures new today! She moves to another trial as their Administrator and
so will be a friendly voice if you need to talk to Mammo-50 at Warwick. We thank Asha
for all her hard work on ARTemis since her return a year ago and wish her well in her new
role. Thank you Asha!
Please contact Clare for general enquiries, and Becky for data queries.
Other Breast Trials
If your ARTemis patients are:

3 years post-curative surgery and

Have a clear mammogram at their three year follow-up appointment
they might be eligible to take part in the Mammo-50 Study.
For more details, please contact mammo-50@warwick.ac.uk
Please be aware that neo-adjuvant HER-2+ patients can be entered into PERSEPHONE.
Herceptin® can be administered either concomitantly or sequentially for 6 or 12 months in
conjunction with chemotherapy. For more details, please contact persephone@warwick.ac.uk
CONTACTS
Phase III Trial
Warwick Clinical Trials Unit, University of Warwick, Gibbet Hill Road, Coventry CV4 7AL
Clare Blenkinsop
: c.blenkinsop@warwick.ac.uk
: 024 7615 1057
ARTemis Fax:
024 7615 1586
Rebecca Lowe
: Rebecca.Lowe@warwick.ac.uk
: 024 7615 1786
Pharmacovigilance, Pharmacy and Translational Studies
Cambridge Cancer Trials Centre, (S4) Box 279, Addenbrookes Hospital, Hills Road, Cambridge CB2 0QQ
Louise Grybowicz
Anne-Laure Vallier
: louise.grybowicz@addenbrookes.nhs.uk
: anne-laure.vallier@addenbrookes.nhs.uk
: 01223 348447
: 01223 348447
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