Overview:
POETIC-A is a phase III, multi-centre randomised trial, which draws on the results of the POETIC trial, to provide a novel but simple mechanism to detect those post-menopausal women with ER+/HER2- primary breast cancer who are at high (20%) 5-year risk of relapse on standard-of-care therapy, and then tests whether a molecular algorithm can identify groups of women who derive greatest benefit from adjuvant treatment with abemaciclib.
The trial is in two parts:
1) A registration part where patients receive between 10 days and 6 months of an aromatase inhibitor (AI) prior to surgery.
2) A randomisation part where patients whose centrally assessed Ki67 remained high at surgery are randomised between standard adjuvant endocrine therapy (ET) alone vs. ET + abemaciclib for two years. Trial treatment will be initiated following completion of standard of care non-endocrine therapy adjuvant treatment.
POETIC-A is open to recruitment and plans to open across 80 UK centres. It is anticipated that approximately 8000 patients will be registered in order to randomise 2032 patients.
Aims:
The primary aim of POETIC-A is to determine the benefit of adding abemaciclib to standard adjuvant ET in a sub-population of ER+/HER2- breast cancer who exhibit early evidence suggestive of sub-optimal endocrine responsiveness and high risk of disease relapse.
A key secondary aim is to determine whether a molecular algorithm (Aromatase Inhibitor Resistant-CDK4/6 Inhibitor Sensitive [“AIR-CIS”]) can identify those women who may derive greatest benefit from additional adjuvant therapy with abemaciclib.
Inclusion criteria:
Key Registration criteria:
- Post-menopausal women
- Operable invasive breast cancer with a clinical/radiological tumour size of ≥1.5cm
- ER+, HER2- or HER2 status unknown (only confirmed HER2 status negative will be eligible for randomisation)
- Received or planned to receive 10 days to 6 months of AI prior to surgery
- No evidence of metastatic disease
Key Randomisation criteria:
- Centrally confirmed Ki67 ≥8% following pre-surgical AI.
- Treatment planned to start within 3 months after completion of definitive surgery and recovery from acute effects of completed adjuvant chemotherapy and/or radiotherapy
- No prior treatment with CDK4/6 inhibitor nor planned abemaciclib treatment as standard of care
Update from the POETIC-A Chief Investigator - November 2021
Website:
Contact:
ICR-CTSU POETIC-A Trial Manager
Telephone: +44 203 437 6858
POETIC-A-icrctsu@icr.ac.uk