ARTemis: Avastin® Randomised Trial with neo-adjuvant chemotherapy for patients with early breast cancer ARTemis Newsletter Issue 19 June 2014 Welcome to this nineteenth edition which will tell you about ASCO June 2014, Surgery Pathology Reports, Translational Sub-Studies, Data, Site Signature Delegation Log & Other Breast Trials. ASCO June 2014 ARTemis pathCR results were presented in the poster highlight session and a poster was displayed at ASCO June 2014! It was titled “ARTemis: A randomised trial of bevacizumab with neoadjuvant chemotherapy (NACT) for patients with HER2-negative early breast cancer—Primary endpoint, pathological complete response (pCR)” and you can read more at http://abstracts.asco.org/144/AbstView_144_129455.html Our ARTemis team of our CIs, Helena Earl and Larry Hayward, TMG members John Bartlett and David Cameron, and Trial Co-ordinator Louise Grybowicz were on hand to answer the many questions from the delegates. Photo: Helena & Larry at ASCO 2014 Surgery Pathology Reports A big thank you to everyone for sending in their surgery pathology reports. Our reviewers were delighted we met their deadlines for submission and to receive 100% of expected reports. We are still hard at work on the secondary endpoints and translational research for future publications, and we’ll let you know when we have these results. Page 1 of 2 Translational Sub-Studies We have collected 89% of the mandatory blood samples so far, thank you to all who have worked hard to obtain and send these samples in to us. Louise will email a site-specific reminder soon, containing a list of the patients whose samples have not yet been collected at each site, so please remember to set a reminder to obtain these mandatory blood samples at your patient’s next follow-up visit. We have 104 patients registered from 18 sites for the SCARF sub-study. This is fantastic in such a short space of time, so thank you very much for talking to patients about the sub-study, and receiving their consents. 20 sites have yet to register their first patient, so please let us know if you require kits or have any questions. 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. Data If there are outstanding diagnostic pathology reports to send in, please do make sure that all personal ID is removed from the report before posting to us. 12 & 24 month Quality of Life Questionnaire and Annual Follow-up Forms continue to be completed at clinic visits. Please send in these and all remaining Treatment Forms, Treatment Summary Forms and any Relapse/Death Forms. Your hard work in answering our queries, and completing the CRFs is much appreciated—thank you! Site Signature & Delegation Log The Site Signature & Delegation Log is updated to include contact details for new starters going forward. To help cut down on paperwork now the trial is in follow-up, Registration/Contact Forms do not have to be completed by new trial staff who sign the new Log, but new Pathologists/Radiologists must complete a Contact Form if they cannot sign the Site Signature & Delegation Log. 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 Asha Bhandari : asha.bhandari@warwick.ac.uk : 024 7615 1072 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 Page 2 of 2