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POETIC

Trial of perioperative endocrine therapy - individualising care.

Disease site: Breast cancer

Treatment modality: Systemic therapy

Status: In follow up

Trial details

POETIC is a phase III, multicentre, randomised trial for postmenopausal women with ER/PR positive invasive breast cancer to determine whether 2 weeks perioperative aromatase inhibitor (AI) therapy before and after surgery improves outcome compared with standard adjuvant therapy alone.

Translational work will determine the most effective time points for molecular profiling and measurement of proliferation marker Ki67 in order to predict long term outcome and time to recurrence, respectively.

4,486 patients were recruited from 130 UK sites over a 5.5 year period. Patients received either perioperative therapy with an AI for 4 weeks (two weeks before and two weeks after surgery) or no perioperative therapy. We are now following up patients annually for at least 10 years.

To learn and understand more about your diagnosis, and the care and treatment you receive, we have asked your permission to access information in your NHS medical records about your health conditions, treatment, progress, and (in the event of your passing away for whatever reason) mortality information. To do this your NHS number and date of birth was securely shared by the PHE National Cancer Registration and Analysis Service (NCRAS) to allow your records to be located. Data supplied by NCRAS will relate to your cancer and care over time, and will be linked to the information obtained from your hospital as part of the trial. All the information shared with NCRAS will be governed by strict rules covering data protection and confidentiality. You can read more about NCRAS: https://www.ndrs.nhs.uk/. You can find out more about how we will protect your information here: https://www.icr.ac.uk/legal/privacy/research-privacy-notice.

Further information for potential participants

Patient Information Sheet (Non biological centres)

Patient Information Sheet(pathway A)

Patient Information Sheet(pathway B)

Further information for healthcare professionals

Protocol

Further information

Chief Investigator: Professor Ian Smith, The Royal Marsden NHS Foundation Trust

ICR-CTSU Scientific Lead: Professor Judith Bliss

Trial management contact: [email protected]

ISRCTN: 63882543

Sponsors: The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust

Funding: Cancer Research UK (CRUK/07/015)

View POETIC on the National Institute for Health Research website: NIHR - Be Part Of Research

Patient friendly information is available from Cancer Research UK.

Publications and presentations

Dowsett M, Smith I, Robertson J, Robison L, Pinhel I, Johnson L, Salter J, Dunbier A, Anderson H, Ghazoui Z, Skene A, Evans A, A’Hern R, Iskender A, Wilcox M, Bliss J. Endocrine therapy, new biologicals, and new study designs for presurgical studies in breast cancer. J Natl Cancer Inst Monogr. 2011; 43: 120–123.

Smith IE, Johnson L, Dowsett M, Robertson JFR, Robison LE, Kokan JS, Evans AA, Holcombe C, Horgan K, Skene A, Prasad R, Absar MS, Vidya R, Bundred NJ, Harding-Mackean C, Wheatley DA, Kissin MW, Pinhel IF, Kilburn LS, Bliss JM; on behalf of the POETIC Trialists. Trial of perioperative endocrine therapy - individualising care (POETIC): a UK success story. J Clin Oncol. 2011; 29(15 Suppl): TPS117.

Bliss JM, Robison L, Webster-Smith M, Emson M, Kilburn LS, Smith IE, Robertson J, Dowsett M, Bundred N, Cameron D, Vidya R, Horgan K, Evans A, Kokan J, Pinhel IF, A’Hern R; on behalf of the POETIC & EPHOS-B Trialists. A trial model for the future in the search for personalized medicine – the UK POETIC & EPHOS-B perioperative trials experience. Cancer Res. 2011; 71(24 Suppl 3): OT2-03-04.

Clinical trials

Division of Clinical Studies

The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.