POETIC-A

Overview:

POETIC-A is a phase III, multi-centre, biomarker-stratified 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. Randomisation takes place 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 2500 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.
  • Patient must have undergone definitive surgery for the primary breast tumour with clear radial margins as judged by MDT.
  • Patient must have recovered from acute effects of completed adjuvant chemotherapy and/or radiotherapy

Update from the POETIC-A Chief Investigator - November 2021

Website:

https://www.icr.ac.uk/our-research/centres-and-collaborations/centres-at-the-icr/clinical-trials-and-statistics-unit/clinical-trials/poetic-a

Contact

ICR-CTSU Poetic-A Trial Manager

Telephone: +44 203 437 6647

Poetic-A-icrctsu@icr.ac.uk