POETIC-A

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 remains open to randomisation of patients already registered and who become eligible by virtue of their high Ki67 test result; the study closed for new registrations on 7 October 2024. 

Objectives

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 ≥1.0cm
• 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

Contact information

ICR-CTSU POETIC-A Trial Manager

Telephone: +44 203 437 6858

POETIC-A-icrctsu@icr.ac.uk