Pre-Operative Endocrine Therapy for Individualised Care with Abemaciclib
Disease site: Breast cancer
Treatment modality: Systemic therapy
Status: Open to recruitment
POETIC-A is a phase III, multicentre trial that tests whether a new drug called abemaciclib, given in combination with standard endocrine therapy (ET), is more effective than giving ET alone. Patients must be post-menopausal, have operable invasive breast cancer which is ER positive and HER2 negative, with high 5-year risk of relapse (defined as ‘high’ baseline Ki67 [≥8%] following treatment with a short course of endocrine therapy (ET) prior to surgery).
The trial has 2 parts: i) a screening-registration part, followed by; ii) a randomised intervention part.
1. Patients may consent to the registration part of the trial at diagnosis and will be given ET for 2 weeks prior to their surgery.
2. Patients who were given ET for between 2 weeks and 6 months prior to their surgery as part of their standard treatment may consent to the registration part of the trial at any point from starting their ET through to being post-surgery and receiving their standard adjuvant treatment.
All patients are asked to donate some tumour tissue collected during surgery.
A biological marker called Ki67 will be measured in the tumour tissue from surgery. Measuring Ki67 tells us how quickly cancer cells are growing and dividing. If this marker is confirmed to still be ‘high’ after at least two weeks of treatment with ET, it could mean that the patient may be less sensitive to standard endocrine treatment and has a higher risk of relapse. These patients will be invited to join the treatment part of the trial, after any planned non-ET treatment has been completed. Up to 8,000 patients will be registered over 3 years, of who approximately 2,500 will be randomised.
Everyone who agrees to join this study will be randomly assigned to one of two treatment groups:
- Group 1: Standard endocrine therapy alone
- Group 2: Standard endocrine therapy and abemaciclib
All randomised patients will take ET for at least 5 years, and those patients randomised to also receive abemaciclib will take it for 2 years. Patients will be followed up (including research blood tests) for 5 years.
Chief Investigator: Professor Stephen Johnston, The Royal Marsden NHS Foundation Trust
Coordinating Investigator: Dr Alistair Ring, The Royal Marsden NHS Foundation Trust
ICR-CTSU Scientific/Methodology Lead: Professor Judith Bliss, The Institute of Cancer Research
Surgical Lead: Professor Cliona Kirwan, University of Manchester and Manchester University NHS Foundation Trust
Translational Study Lead: Professor Mitchell Dowsett, The Ralph Lauren Centre for Breast Cancer Research, The Royal Marsden NHS Foundation Trust
Bioinformatics and Genomics Analysis Lead: Dr Maggie Cheang, The Institute of Cancer Research
Trial management contact: [email protected]
ClinialTrials.gov Identifier: NCT04584853
Sponsor: The Institute of Cancer Research (ICR)
Funding: Lilly and Cancer Research UK (via ICR-CTSU programme)
More information about the POETIC-A trial can be found on the NIHR Be Part of Research website here. A plain English summary from Cancer Research UK can be found here.
Publications and Presentations
Update from the POETIC-A Chief Investigator - November 2021
Update from the POETIC-A Chief Investigator - May 2022
POETIC-A Videos for Study Patients