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Breast CancerPhase 3POETICNCT02338310

Trial of Perioperative Endocrine Therapy - Individualising Care

A Phase 3 study testing Aromatase Inhibitors in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 128 sites in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Aromatase Inhibitors
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,486 participants
Where
128 sitesUnited Kingdom
Study dates
Sep 2008to Apr 2034
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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.

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

Trial locations and contacts

128 sites in 1 country.

128 sites in 1 country

United Kingdom128 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • Bronglais District General Hospital

    Aberystwyth, Wales, SY23 1ER

  • Wansbeck General Hospital

    Ashington, England, NE63 9JJ

  • Tameside General Hospital

    Ashton-under-Lyne

  • Stoke Mandeville Hospital

    Aylesbury, Buckinghamshire, HP21 8AL

  • Ysbyty Gwynedd

    Bangor

  • Barnsley District General Hospital

    Barnsley, South Yorkshire, S75 2EP

  • North Devon District Hospital

    Barnstaple, England, EX31 4JB

  • Royal United Hospital

    Bath

  • Belfast City Hospital

    Belfast, Northern Ireland, BT9 7AB

  • City Hospital - Birmingham

    Birmingham, England, B18 7QH

  • Queen Elizabeth Hospital

    Birmingham

  • Royal Blackburn Hospital

    Blackburn, England, BB2 3HH

  • Royal Bolton Hospital

    Bolton

  • Pilgrim Hospital

    Boston, England, PE21 9QT

  • Royal Bournemouth General Hospital

    Bournemouth

  • Bradford Teaching Hospitals NHS Trust, St Luke's Hospital

    Bradford, England, BD5 0NA

  • Bristol Royal Infirmary

    Bristol

  • Southmead Hospital

    Bristol

  • Burnley General Hospital

    Burnley, England, BB10 2PQ

  • Addenbrooke's Hospital

    Cambridge

  • East Kent Hospitals

    Canterbury

  • University Hospital Of Wales

    Cardiff

  • Cumberland Infirmary

    Carlisle, England, CA2 7HY

  • Chelmsford and Essex Centre

    Chelmsford, England, CM2 0QH

  • Ashford and St Peter's Hospitals

    Chertsey, Surrey, KT16 0PZ

  • Countess of Chester Hospital

    Chester, England, CH2 1UL

  • Chesterfield Royal Hospital

    Chesterfield, England, S44 5BL

  • Essex County Hospital

    Colchester, England, C03 3NB

  • Castle Hill Hospital

    Cottingham

  • University Hospital Coventry

    Coventry, CV2 2DX

  • Leighton Hospital

    Crewe

  • Darent Valley Hospital

    Dartford

  • Royal Derby Hospital

    Derby

  • Doncaster Royal Infirmary

    Doncaster, England, DN2 5LT

  • Russells Hall Hospital

    Dudley, England, DY1 2HQ

  • Dumfries & Galloway Royal Infirmary

    Dumfries, Scotland, DG1 4AP

  • Ninewells Hospital

    Dundee, Scotland, DD1 9SY

  • Ulster Hospital

    Dundonald, Belfast, BT16 1RH

  • St Margaret's Hospital

    Epping, Essex, CM16 6TN

  • Royal Devon and Exeter Hospital

    Exeter

  • Frimley Park Hospital

    Frimley

  • Medway Maritime Hospital

    Gillingham, Kent, ME7 5NY

  • Western Infirmary

    Glasgow, G11 6NT

  • Cheltenham General Hospital

    Gloucester, Gloucs

  • Grantham and District Hospital

    Grantham, Lincolnshire, NG31 8DG

  • Royal Surrey County Hospital

    Guildford

  • Harrogate District Hospital

    Harrogate, North Yorkshire, HG2 7SX

  • Withybush General Hospital

    Haverfordwest, Wales, SA61 2PZ

  • Hereford County Hospital

    Hereford, HR1 2ER

  • Wycombe General Hospital

    High Wycombe, England

  • Huddersfield Royal Infirmary

    Huddersfield

  • Ipswich Hospital

    Ipswich

  • Airedale General Hospital

    Keighley, England, BD20 6TD

  • Kidderminster Hospital

    Kidderminster, England, DY11 6RJ

  • Kingston Hospital

    Kingston upon Thames, Surrey, KT2 7QB

  • Leeds General Infirmary/ St James' University Hospital

    Leeds, LS1 3EX

  • University Hospitals of Leicester NHS Trust

    Leicester, LE3 9QP

  • University Hospital, Lewisham

    Lewisham, London, SE13 6LH

  • Lincoln County Hospital

    Lincoln

  • Royal Liverpool University Hospital

    Liverpool

  • Prince Philip Hospital

    Llanelli, Carmarthenshire, SA14 8QF

  • Whittington Hospital

    London, England, N19 5NF

  • Royal Free Hospital

    London, England, NW3 2QG

  • Guy's Hospital

    London, England, SE1 9RT

  • King's College Hospital

    London, England, SE5 9RS

  • Royal Marsden - London

    London, England, SW3 6JJ

  • St. Mary's Hospital

    London, England, W2 1NY

  • Homerton University Hospital

    London, E9 6SR

  • Charing Cross Hospital

    London

  • Northwick Park Hospital

    London

  • St Bartholomew's Hospital

    London

  • Luton and Dunstable Hospital

    Luton

  • Macclesfield District General Hospital

    Macclesfield

  • Maidstone Hospital

    Maidstone

  • Wythenshawe Hospital

    Manchester, England, M23 9LJ

  • North Manchester General Hospital - Penine Actute Hospitals Trust

    Manchester, England, M8 6RB

  • Hillingdon Hospital

    Middlesex

  • Milton Keynes General Hospital

    Milton Keynes

  • Royal Victoria Infirmary

    Newcastle, Newcastle-Upon-Tyne, NE1 4LP

  • North Tyneside Hospital

    North Shields, England, NE29 8NH

  • Northampton General Hospital NHS Trust

    Northampton, England, NN6 8BJ

  • Norfolk and Norwich University Hospital

    Norwich

  • Nottingham City Hospital

    Nottingham

  • George Eliot Hospital

    Nuneaton, England, CV10 7DJ

  • Royal Oldham Hospital

    Oldham, England, OL1 2JH

  • Princess Royal University Hospital

    Orpington, Kent, BR6 8ND

  • Derriford Hospital

    Plymouth

  • Dorset County Hospital

    Poole

  • Poole Hospital

    Poole Dorset, England, BH15 2JB

  • Neath Port Talbot Hospital

    Port Talbot, West Glamorgan, SA12 7BX

  • Craigavon Area Hospital

    Portadown, Co.Amagh, BT63 5QQ

  • Royal Berkshire Hospital

    Reading, England, RG1 5AN

  • East Surrey Hospital

    Redhill, Surrey, RH1 5RH

  • North Wales CTC, Glan Clwyd Hospital

    Rhyl, Wales, LL18 5UJ

  • Queen's Hospital,

    Romford

  • Rotherham District General Hospital

    Rotherham, South Yorkshire, S60 2UD

  • Tunbridge Wells Hospital

    Royal Tunbridge Wells, Kent, TN2 4QL

  • Salford Royal Hospital

    Salford, M6 8HD

  • Salisbury District Hospital

    Salisbury

  • Weston Park Hospital

    Sheffield

  • Heatherwood and Wexham Park Hospitals NHS trust

    Slough, Berkshire, SL2 4HL

  • Ealing Hospital

    Southall, Middlesex, UB1 3HW

  • Southampton General Hospital

    Southampton

  • St Albans City Hospital

    St Albans, Hertfordshire, AL3 5PN

  • Staffordshire General Hospital

    Stafford, ST16 3SA

  • Stepping Hill Hospital

    Stockport

  • University Hospital of North Tees

    Stockton-on-Tees, TS19 8PE

  • University Hospital of North Staffordshire

    Stoke-on-Trent, England, ST4 7LN

  • Royal Marsden Hosital,

    Sutton, England, SM2 5PT

  • Singleton Hospital

    Swansea, Wales, SA 2 8QA

  • Musgrove Park Hospital

    Taunton

  • Princess Royal Hospital

    Telford, Shropshire, TF1 6TF

  • St George's Hospital,

    Tooting

  • Torbay District General Hospital

    Torquay, TQ2 7AA

  • Royal Cornwall Hospital

    Truro, TR1 3LJ

  • Mid Yorkshire Hospitals

    Wakefield

  • Warwick Hospital

    Warwick, CV34 5BW

  • Queen Elizabeth II Hospital

    Welwyn Garden City, Hertfordshire, AL7 4HQ

  • Southend NHS Trust Hospital

    Westcliff-on-Sea, England, SS0 0RY

  • Weston General Hospital, Avon

    Weston-super-Mare, Somerset, BS23 4TQ

  • Royal Albert Edward Infirmary

    Wigan

  • Royal Hampshire County Hospital

    Winchester, England, SO22 5DG

  • New Cross Hospital

    Wolverhampton, England, WV10 0QP

  • Queen Elizabeth Hospital

    Woolwich, London, SE18 4QH

  • Worcester Royal Hospital

    Worcester, England, WR5 1DD

  • Worthing Hospital

    Worthing

  • Yeovil District Hospital

    Yeovil, England, BA21 4AT

Other trials in United Kingdom

About this study

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.

Conditions
Breast Cancer
Being tested
Aromatase Inhibitors
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aromatase InhibitorsDrug

    Also called Anastrazole, Letrozole

    Choice of AI is according to centre policy; any brand can be used

Study groups in NCT02338310
Study groupRoleWhat they receive
No Aromatase InhibitorNo interventionNo aromatase inhibitor given around the time of surgery
Aromatase InhibitorExperimentalAromatase 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)
Receives: Drug: Aromatase Inhibitors

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 years post-randomisation

Secondary outcomes (7)

  1. Relapse free survival

    Second primary cancers and deaths from non-breast cancer causes in the absence of breast cancer relapse will be treated as censoring events.

    Measured: 5 years post-randomisation

  2. Time to local recurrence

    Measured: 5 years post-randomisation

  3. Time to distant recurrence

    Measured: 5 years post-randomisation

  4. Overall Survival

    Measured: 5 years post-randomisation

  5. Breast cancer free survival

    Measured: 5 years post-randomisation

  6. Proliferation rate (Ki67)

    Comparison of the predictive value of Ki67 at surgery in the perioperative therapy and non perioperative therapy groups will be undertaken using Cox regression, comparing the estimates of the hazard ratios obtained in each treatment group.

    Measured: At time of surgery (around 2 weeks post-randomisation)

  7. Gene expression profile

    Measured: At time of surgery (around 2 weeks post-randomisation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2015 (estimated)
  2. Study startSep 2008
  3. Primary completionApr 2024 (estimated)
  4. Study completionApr 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,486 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02338310
Sponsor's protocol ID
ICR-CTSU/2007/10015
Other IDs
2007-003877-21, CRUK/07/015, 08/H1102/37, 63882543, CCR 2973
Acronym
POETIC
Status last verified
Feb 2020
First submitted
16 Sep 2014
Last updated
17 Feb 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33152284

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aromatase Inhibitors in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 128 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 128 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to recurrence (time frame: 5 years post-randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02338310, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.

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