Trial of Perioperative Endocrine Therapy - Individualising Care
POETIC
6 other identifiers
interventional
4,486
1 country
128
Brief Summary
To determine whether perioperative endocrine therapy with an aromatase inhibitor (AI) followed by standard adjuvant therapy improves outcome compared with standard adjuvant therapy alone in postmenopausal women with hormone receptor positive breast cancer. To determine whether the proliferation marker Ki67 as measured by immunohistochemistry (IHC) in the excised cancer around 2 weeks after starting AI therapy will predict for time to recurrence (TTR) in the individual patient more effectively than the pre-treatment Ki67 value. To determine whether molecular profiling 2 weeks after starting endocrine therapy predicts for long-term outcome in postmenopausal women with hormone receptor positive breast cancer better than at diagnosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Sep 2008
Longer than P75 for phase_3 breast-cancer
128 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 16, 2014
CompletedFirst Posted
Study publicly available on registry
January 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2034
ExpectedFebruary 17, 2020
February 1, 2020
15.6 years
September 16, 2014
February 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Time to recurrence
Time to recurrence (TTR) is defined as 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. Patients who are alive and disease free will be censored at the date last seen alive.
5 years post-randomisation
Secondary Outcomes (7)
Relapse free survival
5 years post-randomisation
Time to local recurrence
5 years post-randomisation
Time to distant recurrence
5 years post-randomisation
Overall Survival
5 years post-randomisation
Breast cancer free survival
5 years post-randomisation
- +2 more secondary outcomes
Study Arms (2)
No Aromatase Inhibitor
NO INTERVENTIONNo aromatase inhibitor given around the time of surgery
Aromatase Inhibitor
EXPERIMENTALAromatase Inhibitor given perioperatively for 4 weeks (two weeks before and two weeks after surgery) Choice of AI is according to centre policy and may be either anastrozole (1mg/day) or letrozole (2.5mg/day)
Interventions
Choice of AI is according to centre policy; any brand can be used
Eligibility Criteria
You may qualify if:
- Post menopausal women with core biopsy-proven hormone receptor positive invasive breast cancer. Postmenopausal is defined as a woman aged ≥50 years fulfilling any one of the following criteria:
- i) with amenorrhoea \>12 months and an intact uterus; ii) has undergone a bilateral oophorectomy; iii) in women who have undergone a hysterectomy, then FSH levels within the postmenopausal range (utilising ranges from the testing laboratory facility) are required if the patient is aged \<55 years; or iv) in women who have been on HRT within the last 12 months and therefore not amenorrhoeic, FSH levels within the postmenopausal range (utilising ranges from the testing laboratory facility) are required if the patient is aged \<55 years.
- No evidence of metastatic spread by standard assessment according to local guidelines
- Standard adjuvant endocrine therapy indicated
- A palpable tumour of any size , or a tumour with an ultrasound size of at least 1.5cm
- WHO performance status of 0 or 1
- Written informed consent to participate in the trial and to donation of tissue (fresh tissue and surplus tissue from diagnostic procedures) and blood samples.
You may not qualify if:
- Locally advanced/inoperable breast cancer
- Evidence of metastatic disease
- Previous invasive breast cancer (surgically treated DCIS or LCIS allowed)
- Current bilateral breast cancer
- Multiple unilateral tumours with different ER/PgR/HER2 status, grade or type (e.g. ductal vs lobular) i.e. anything that suggests two or more different cancers. Multifocal disease with homogenous ER/PgR/HER2 status, grade and type is allowed if at least one lesion is palpable or at least 1.5cm on ultrasound; the largest lesion should be used for sample collection and CRF completion.
- Concurrent use (defined as use within 4 weeks prior to diagnostic tissue sample being taken) of HRT or any other oestrogen-containing medication (including vaginal oestrogens)
- Previous use of oestrogen implants at ANY time
- Prior endocrine therapy or chemotherapy for breast cancer
- Any invasive malignancy diagnosed within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ)
- Any severe co-incident medical disease, inability to give informed consent or unavailability for follow-up
- Treatment with an unlicensed or investigational drug within 4 weeks before randomisation
- Current, continuous, long term systemic steroid usage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (128)
Ulster Hospital
Dundonald, Belfast, BT16 1RH, United Kingdom
Heatherwood and Wexham Park Hospitals NHS trust
Slough, Berkshire, SL2 4HL, United Kingdom
Stoke Mandeville Hospital
Aylesbury, Buckinghamshire, HP21 8AL, United Kingdom
Prince Philip Hospital
Llanelli, Carmarthenshire, SA14 8QF, United Kingdom
Craigavon Area Hospital
Portadown, Co.Amagh, BT63 5QQ, United Kingdom
Wansbeck General Hospital
Ashington, England, NE63 9JJ, United Kingdom
North Devon District Hospital
Barnstaple, England, EX31 4JB, United Kingdom
City Hospital - Birmingham
Birmingham, England, B18 7QH, United Kingdom
Royal Blackburn Hospital
Blackburn, England, BB2 3HH, United Kingdom
Pilgrim Hospital
Boston, England, PE21 9QT, United Kingdom
Bradford Teaching Hospitals NHS Trust, St Luke's Hospital
Bradford, England, BD5 0NA, United Kingdom
Burnley General Hospital
Burnley, England, BB10 2PQ, United Kingdom
Cumberland Infirmary
Carlisle, England, CA2 7HY, United Kingdom
Chelmsford and Essex Centre
Chelmsford, England, CM2 0QH, United Kingdom
Countess of Chester Hospital
Chester, England, CH2 1UL, United Kingdom
Chesterfield Royal Hospital
Chesterfield, England, S44 5BL, United Kingdom
Essex County Hospital
Colchester, England, C03 3NB, United Kingdom
Doncaster Royal Infirmary
Doncaster, England, DN2 5LT, United Kingdom
Russells Hall Hospital
Dudley, England, DY1 2HQ, United Kingdom
Wycombe General Hospital
High Wycombe, England, United Kingdom
Airedale General Hospital
Keighley, England, BD20 6TD, United Kingdom
Kidderminster Hospital
Kidderminster, England, DY11 6RJ, United Kingdom
Whittington Hospital
London, England, N19 5NF, United Kingdom
Royal Free Hospital
London, England, NW3 2QG, United Kingdom
Guy's Hospital
London, England, SE1 9RT, United Kingdom
King's College Hospital
London, England, SE5 9RS, United Kingdom
Royal Marsden - London
London, England, SW3 6JJ, United Kingdom
St. Mary's Hospital
London, England, W2 1NY, United Kingdom
Wythenshawe Hospital
Manchester, England, M23 9LJ, United Kingdom
North Manchester General Hospital - Penine Actute Hospitals Trust
Manchester, England, M8 6RB, United Kingdom
North Tyneside Hospital
North Shields, England, NE29 8NH, United Kingdom
Northampton General Hospital NHS Trust
Northampton, England, NN6 8BJ, United Kingdom
George Eliot Hospital
Nuneaton, England, CV10 7DJ, United Kingdom
Royal Oldham Hospital
Oldham, England, OL1 2JH, United Kingdom
Poole Hospital
Poole Dorset, England, BH15 2JB, United Kingdom
Royal Berkshire Hospital
Reading, England, RG1 5AN, United Kingdom
University Hospital of North Staffordshire
Stoke-on-Trent, England, ST4 7LN, United Kingdom
Royal Marsden Hosital,
Sutton, England, SM2 5PT, United Kingdom
Southend NHS Trust Hospital
Westcliff-on-Sea, England, SS0 0RY, United Kingdom
Royal Hampshire County Hospital
Winchester, England, SO22 5DG, United Kingdom
New Cross Hospital
Wolverhampton, England, WV10 0QP, United Kingdom
Worcester Royal Hospital
Worcester, England, WR5 1DD, United Kingdom
Yeovil District Hospital
Yeovil, England, BA21 4AT, United Kingdom
St Margaret's Hospital
Epping, Essex, CM16 6TN, United Kingdom
Cheltenham General Hospital
Gloucester, Gloucs, United Kingdom
St Albans City Hospital
St Albans, Hertfordshire, AL3 5PN, United Kingdom
Queen Elizabeth II Hospital
Welwyn Garden City, Hertfordshire, AL7 4HQ, United Kingdom
Medway Maritime Hospital
Gillingham, Kent, ME7 5NY, United Kingdom
Princess Royal University Hospital
Orpington, Kent, BR6 8ND, United Kingdom
Tunbridge Wells Hospital
Royal Tunbridge Wells, Kent, TN2 4QL, United Kingdom
Grantham and District Hospital
Grantham, Lincolnshire, NG31 8DG, United Kingdom
University Hospital, Lewisham
Lewisham, London, SE13 6LH, United Kingdom
Queen Elizabeth Hospital
Woolwich, London, SE18 4QH, United Kingdom
Ealing Hospital
Southall, Middlesex, UB1 3HW, United Kingdom
Royal Victoria Infirmary
Newcastle, Newcastle-Upon-Tyne, NE1 4LP, United Kingdom
Harrogate District Hospital
Harrogate, North Yorkshire, HG2 7SX, United Kingdom
Belfast City Hospital
Belfast, Northern Ireland, BT9 7AB, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN, United Kingdom
Dumfries & Galloway Royal Infirmary
Dumfries, Scotland, DG1 4AP, United Kingdom
Ninewells Hospital
Dundee, Scotland, DD1 9SY, United Kingdom
Princess Royal Hospital
Telford, Shropshire, TF1 6TF, United Kingdom
Weston General Hospital, Avon
Weston-super-Mare, Somerset, BS23 4TQ, United Kingdom
Barnsley District General Hospital
Barnsley, South Yorkshire, S75 2EP, United Kingdom
Rotherham District General Hospital
Rotherham, South Yorkshire, S60 2UD, United Kingdom
Ashford and St Peter's Hospitals
Chertsey, Surrey, KT16 0PZ, United Kingdom
Kingston Hospital
Kingston upon Thames, Surrey, KT2 7QB, United Kingdom
East Surrey Hospital
Redhill, Surrey, RH1 5RH, United Kingdom
Bronglais District General Hospital
Aberystwyth, Wales, SY23 1ER, United Kingdom
Withybush General Hospital
Haverfordwest, Wales, SA61 2PZ, United Kingdom
North Wales CTC, Glan Clwyd Hospital
Rhyl, Wales, LL18 5UJ, United Kingdom
Singleton Hospital
Swansea, Wales, SA 2 8QA, United Kingdom
Neath Port Talbot Hospital
Port Talbot, West Glamorgan, SA12 7BX, United Kingdom
Tameside General Hospital
Ashton-under-Lyne, United Kingdom
Ysbyty Gwynedd
Bangor, United Kingdom
Royal United Hospital
Bath, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Royal Bolton Hospital
Bolton, United Kingdom
Royal Bournemouth General Hospital
Bournemouth, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
Southmead Hospital
Bristol, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
East Kent Hospitals
Canterbury, United Kingdom
University Hospital Of Wales
Cardiff, United Kingdom
Castle Hill Hospital
Cottingham, United Kingdom
University Hospital Coventry
Coventry, CV2 2DX, United Kingdom
Leighton Hospital
Crewe, United Kingdom
Darent Valley Hospital
Dartford, United Kingdom
Royal Derby Hospital
Derby, United Kingdom
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Frimley Park Hospital
Frimley, United Kingdom
Western Infirmary
Glasgow, G11 6NT, United Kingdom
Royal Surrey County Hospital
Guildford, United Kingdom
Hereford County Hospital
Hereford, HR1 2ER, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, United Kingdom
Ipswich Hospital
Ipswich, United Kingdom
Leeds General Infirmary/ St James' University Hospital
Leeds, LS1 3EX, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, LE3 9QP, United Kingdom
Lincoln County Hospital
Lincoln, United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom
Homerton University Hospital
London, E9 6SR, United Kingdom
Charing Cross Hospital
London, United Kingdom
Northwick Park Hospital
London, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
Luton and Dunstable Hospital
Luton, United Kingdom
Macclesfield District General Hospital
Macclesfield, United Kingdom
Maidstone Hospital
Maidstone, United Kingdom
Hillingdon Hospital
Middlesex, United Kingdom
Milton Keynes General Hospital
Milton Keynes, United Kingdom
Norfolk and Norwich University Hospital
Norwich, United Kingdom
Nottingham City Hospital
Nottingham, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Dorset County Hospital
Poole, United Kingdom
Queen's Hospital,
Romford, United Kingdom
Salford Royal Hospital
Salford, M6 8HD, United Kingdom
Salisbury District Hospital
Salisbury, United Kingdom
Weston Park Hospital
Sheffield, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Staffordshire General Hospital
Stafford, ST16 3SA, United Kingdom
Stepping Hill Hospital
Stockport, United Kingdom
University Hospital of North Tees
Stockton-on-Tees, TS19 8PE, United Kingdom
Musgrove Park Hospital
Taunton, United Kingdom
St George's Hospital,
Tooting, United Kingdom
Torbay District General Hospital
Torquay, TQ2 7AA, United Kingdom
Royal Cornwall Hospital
Truro, TR1 3LJ, United Kingdom
Mid Yorkshire Hospitals
Wakefield, United Kingdom
Warwick Hospital
Warwick, CV34 5BW, United Kingdom
Royal Albert Edward Infirmary
Wigan, United Kingdom
Worthing Hospital
Worthing, United Kingdom
Related Publications (1)
Smith I, Robertson J, Kilburn L, Wilcox M, Evans A, Holcombe C, Horgan K, Kirwan C, Mallon E, Sibbering M, Skene A, Vidya R, Cheang M, Banerji J, Morden J, Sidhu K, Dodson A, Bliss JM, Dowsett M. Long-term outcome and prognostic value of Ki67 after perioperative endocrine therapy in postmenopausal women with hormone-sensitive early breast cancer (POETIC): an open-label, multicentre, parallel-group, randomised, phase 3 trial. Lancet Oncol. 2020 Nov;21(11):1443-1454. doi: 10.1016/S1470-2045(20)30458-7.
PMID: 33152284DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ian Smith, Professor
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
September 16, 2014
First Posted
January 14, 2015
Study Start
September 1, 2008
Primary Completion
April 1, 2024
Study Completion (Estimated)
April 1, 2034
Last Updated
February 17, 2020
Record last verified: 2020-02