PreOperative Endocrine Therapy for Individualised Care With Abemaciclib
POETIC-A
1 other identifier
interventional
123
1 country
62
Brief Summary
POETIC-A is a phase 3 trial which targets post-menopausal primary breast cancer patients with a high 5-year risk of relapse as determined by a high Ki67 after 2 weeks aromatase inhibitor therapy pre-surgery. Eligible patients will be randomised to standard adjuvant endocrine therapy alone or standard adjuvant endocrine therapy with a CDK4/6 inhibitor called abemaciclib.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2020
Longer than P75 for phase_3
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2020
CompletedFirst Posted
Study publicly available on registry
October 14, 2020
CompletedStudy Start
First participant enrolled
December 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2030
January 14, 2026
January 1, 2026
9.8 years
July 6, 2020
January 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to tumour (local or distant disease) recurrence
the time from randomisation to local, regional or distant tumour recurrence or death from breast cancer without prior notification of relapse. Second primary cancers and intercurrent deaths will be treated as censoring events.
from randomisation until tumour recurrence or patient death, assessed up to 5 years
Secondary Outcomes (7)
Relapse-free-survival
from randomisation until relapse or patient death, assessed up to 5 years
Time to distant recurrence
from randomisation until distant recurrence or patient death, assessed up to 5 years
Breast cancer specific survival
from randomisation until patient death from breast cancer, assessed up to 5 years
Overall survival
from randomisation until patient death, assessed up to 5 years
Patient reported quality of life
5 years from randomisation
- +2 more secondary outcomes
Study Arms (2)
Endocrine Therapy only
ACTIVE COMPARATOREndocrine therapy prescribed as per standard of care, for an expected duration of at least 5 years, or until evidence of disease recurrence or other discontinuation criteria are met. Choice of endocrine therapy may include non-steroidal aromatase inhibitor (letrozole or anastrozole), steroidal aromatase inhibitor (exemestane), or tamoxifen
Endocrine Therapy with abemaciclib
EXPERIMENTALAbemaciclib administered at dose of 150mg twice daily (provided as 50mg tablets), for 2 years or until evidence of disease recurrence or other discontinuation criteria are met. Endocrine therapy prescribed as per standard of care, for an expected duration of at least 5 years, or until evidence of disease recurrence or other discontinuation criteria are met. Choice of endocrine therapy may include non-steroidal aromatase inhibitor (letrozole or anastrozole), steroidal aromatase inhibitor (exemestane), or tamoxifen
Interventions
Abemaciclib used in combination with standard Endocrine Therapy for 2 years from randomisation
Standard of care endocrine therapy for a minimum of 5 years from randomisation
Eligibility Criteria
You may qualify if:
- Women determined to be postmenopausal according to established local criteria.
- Diagnosed operable invasive breast cancer with a clinical/radiological tumour size ≥1.0cm\*
- Grade 2 or 3 tumours
- Preoperative full assessment completed (including bilateral breast examination and imaging with mammogram +/- ultrasound/MRI as performed locally).
- Tumour ER positive. ER positivity is defined as \>/=1% cells staining positive (or equivalent Allred Score of ER \>/=3 out of 8).
- Tumour HER2 negative or HER2 status unknown. HER2 negativity will be defined as per the 2018 ASCO/CAP updated guidelines. Patients whose HER2 status is pending/unknown at the time of registration will be allowed to register to the trial. However, please note that only patients who are confirmed to be HER2 negative will be eligible to join the randomised part.
- Received or planned to receive 10 days to 6 months of anastrozole or letrozole prior to surgery.
- Written informed consent to enter the registration stage of the trial and to donation of fresh tissue.
- The patient has given written informed consent prior to any study-specific procedures and is willing and able to make herself available for the duration of the study and amenable and able to follow study schedule during treatment and follow-up and for the use of routinely collected electronic health and related records.
You may not qualify if:
- Men and pre/perimenopausal women.
- Intended or actual use of HRT or any other oestrogen-containing medication (including vaginal oestrogens) within 4 weeks prior to planned surgery). Note: patient with a Mirena coil in situ at the time of registration are not excluded.
- Patients who commenced pre-surgical AI therapy \>6 months prior to surgery.
- Prior endocrine therapy for breast cancer or breast cancer prevention.
- Prior neoadjuvant chemotherapy for breast cancer.
- Evidence of metastatic disease.
- Locally advanced breast cancer not amenable to surgery.
- Bilateral invasive breast cancer (excluding contralateral DCIS/LCIS).
- Multiple unilateral tumours with different ER and/or HER2 status. Synchronous DCIS/LCIS, as well as multifocal disease with homogenous ER/HER2 status is allowed if at least one lesion is at least 1.0cm; the largest lesion should be used for sample collection and CRF completion. If ER/HER2 status of smaller foci is unknown at time of registration, patients can be registered; however, note that congruity of receptor status will need to be confirmed by the time of randomisation, unless smaller foci are \<10mm and receptor status is unknown.
- Previous invasive breast cancer except for ipsilateral DCIS or LCIS treated \>5 years previously by locoregional therapy alone or contralateral DCIS/LCIS treated by locoregional therapy at any time.
- Any invasive malignancy diagnosed within previous 5 years (other than non-melanoma skin cancer or cervical carcinoma in situ).
- Patient previously consented and registered for screening component of POETIC-A.
- Tumour HER2 negative. HER2 negativity will be defined as per the 2018 ASCO/CAP updated guidelines
- Centrally confirmed Ki67 \>/=8% following 2 weeks of AI.
- Patient is expected by the time of treatment initiation to have undergone definitive surgery for the primary breast tumour with clear radial margins as judged by the multidisciplinary team, and will have completed any adjuvant chemotherapy or radiotherapy (if prescribed).
- +28 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom
Royal Devon & Exeter Hospital
Exeter, Devon, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, England, PE30 4ET, United Kingdom
Great Western Hospital
Swindon, England, SN3 6BB, United Kingdom
Northampton General Hospital
Northampton, Northants, United Kingdom
Belfast City Hospital
Belfast, Northern Ireland, United Kingdom
Forth Valley Royal Hospital
Larbert, Scotland, FK5 4WR, United Kingdom
Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Wansbeck General Hospital
Ashington, United Kingdom
Ysbyty Gwynedd
Bangor, United Kingdom
Royal United Hospital Bath
Bath, United Kingdom
Royal Blackburn Hospital
Blackburn, BB2 3HH, United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom
Pilgrim Hospital
Boston, United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom
Burnley General Hospital
Burnley, BB10 2PQ, United Kingdom
Doncaster Royal Infirmary
Doncaster, United Kingdom
Dumfries and Galloway Royal Infirmary
Dumfries, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Calderdale Royal Hospital
Halifax, United Kingdom
Harrogate District Hospital
Harrogate, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, United Kingdom
Ipswich Hospital
Ipswich, IP4 5PD, United Kingdom
Kettering General Hospital
Kettering, United Kingdom
Kingston Hospital
Kingston upon Thames, United Kingdom
University Hospitals of Morecambe Bay
Lancaster, United Kingdom
St James's University Hospital
Leeds, United Kingdom
Lincoln County Hospital
Lincoln, United Kingdom
St John's Hospital
Livingston, United Kingdom
Barnet and Chase Farm Hospitals
London, United Kingdom
Charing Cross Hospital
London, United Kingdom
Royal Free Hospital
London, United Kingdom
Royal Marsden NHS Foundation Trust
London, United Kingdom
St George's Hospital
London, United Kingdom
University College London
London, United Kingdom
Maidstone and Tunbridge Wells NHS Trust
Maidstone, United Kingdom
North Manchester General Hospital
Manchester, United Kingdom
The Christie Hospital
Manchester, United Kingdom
Wythenshawe Hospital
Manchester, United Kingdom
Borders General Hospital
Melrose, United Kingdom
Milton Keynes University Hospital
Milton Keynes, United Kingdom
North Tyneside General Hospital
North Shields, United Kingdom
George Eliot Hospital NHS Trust
Nuneaton, United Kingdom
University Hospital Llandough
Penarth, United Kingdom
Poole General Hospital
Poole, United Kingdom
Royal Berkshire Hospital
Reading, United Kingdom
East Surrey Hospital
Redhill, United Kingdom
Glan Clwyd
Rhyl, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, United Kingdom
Southampton General Hospital
Southampton, SO166YD, United Kingdom
University Hospitals of North Tees and Hartlepool
Stockton-on-Tees, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom
Royal Marsden Hospital
Sutton, United Kingdom
Musgrove Park Hospital
Taunton, United Kingdom
Mid Yorkshire -Pinderfields Hospital
Wakefield, WF1 4DG, United Kingdom
Warwick Hospital
Warwick, United Kingdom
Royal Albert Edward Infirmary
Wigan, United Kingdom
Worcestershire Acute Hospitals NHS Trust
Worcester, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Johnston
Royal Marsden NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2020
First Posted
October 14, 2020
Study Start
December 23, 2020
Primary Completion (Estimated)
October 1, 2030
Study Completion (Estimated)
October 1, 2030
Last Updated
January 14, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will be shared once primary results have been published and other key analyses have been completed.
- Access Criteria
- Access will need to be requested via the institution's data access request form (available upon request from poetic-a-icrctsu@icr.ac.uk).
The datasets generated and/or analysed during the study will be available on request from the POETIC-A trial team via poetic-a-icrctsu@icr.ac.uk via completion of a data access request form after such time that the primary analysis publication and any other key analyses have been completed. Optional advanced consent/authorisation for the possible future sharing of information collected about patients will be obtained at study entry.