Breast Cancer Clinical Trial
— POETIC| Verified date | February 2020 |
| Source | Institute of Cancer Research, United Kingdom |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 4486 |
| Est. completion date | April 2034 |
| Est. primary completion date | April 2024 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 50 Years and older |
| Eligibility |
Inclusion Criteria: 1. 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. 2. No evidence of metastatic spread by standard assessment according to local guidelines 3. Standard adjuvant endocrine therapy indicated 4. A palpable tumour of any size , or a tumour with an ultrasound size of at least 1.5cm 5. WHO performance status of 0 or 1 6. Written informed consent to participate in the trial and to donation of tissue (fresh tissue and surplus tissue from diagnostic procedures) and blood samples. Exclusion Criteria: 1. Locally advanced/inoperable breast cancer 2. Evidence of metastatic disease 3. Previous invasive breast cancer (surgically treated DCIS or LCIS allowed) 4. Current bilateral breast cancer 5. 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. 6. 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) 7. Previous use of oestrogen implants at ANY time 8. Prior endocrine therapy or chemotherapy for breast cancer 9. Any invasive malignancy diagnosed within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ) 10. Any severe co-incident medical disease, inability to give informed consent or unavailability for follow-up 11. Treatment with an unlicensed or investigational drug within 4 weeks before randomisation 12. Current, continuous, long term systemic steroid usage |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Aberdeen Royal Infirmary | Aberdeen | Scotland |
| United Kingdom | Bronglais District General Hospital | Aberystwyth | Wales |
| United Kingdom | Wansbeck General Hospital | Ashington | England |
| United Kingdom | Tameside General Hospital | Ashton-Under-Lyne | |
| United Kingdom | Stoke Mandeville Hospital | Aylesbury | Buckinghamshire |
| United Kingdom | Ysbyty Gwynedd | Bangor | |
| United Kingdom | Barnsley District General Hospital | Barnsley | South Yorkshire |
| United Kingdom | North Devon District Hospital | Barnstaple | England |
| United Kingdom | Royal United Hospital | Bath | |
| United Kingdom | Belfast City Hospital | Belfast | Northern Ireland |
| United Kingdom | City Hospital - Birmingham | Birmingham | England |
| United Kingdom | Queen Elizabeth Hospital | Birmingham | |
| United Kingdom | Royal Blackburn Hospital | Blackburn | England |
| United Kingdom | Royal Bolton Hospital | Bolton | |
| United Kingdom | Pilgrim Hospital | Boston | England |
| United Kingdom | Royal Bournemouth General Hospital | Bournemouth | |
| United Kingdom | Bradford Teaching Hospitals NHS Trust, St Luke's Hospital | Bradford | England |
| United Kingdom | Bristol Royal Infirmary | Bristol | |
| United Kingdom | Southmead Hospital | Bristol | |
| United Kingdom | Burnley General Hospital | Burnley | England |
| United Kingdom | Addenbrooke's Hospital | Cambridge | |
| United Kingdom | East Kent Hospitals | Canterbury | |
| United Kingdom | University Hospital Of Wales | Cardiff | |
| United Kingdom | Cumberland Infirmary | Carlisle | England |
| United Kingdom | Chelmsford and Essex Centre | Chelmsford | England |
| United Kingdom | Ashford and St Peter's Hospitals | Chertsey | Surrey |
| United Kingdom | Countess of Chester Hospital | Chester | England |
| United Kingdom | Chesterfield Royal Hospital | Chesterfield | England |
| United Kingdom | Essex County Hospital | Colchester | England |
| United Kingdom | Castle Hill Hospital | Cottingham | |
| United Kingdom | University Hospital Coventry | Coventry | |
| United Kingdom | Leighton Hospital | Crewe | |
| United Kingdom | Darent Valley Hospital | Dartford | |
| United Kingdom | Royal Derby Hospital | Derby | |
| United Kingdom | Doncaster Royal Infirmary | Doncaster | England |
| United Kingdom | Russells Hall Hospital | Dudley | England |
| United Kingdom | Dumfries & Galloway Royal Infirmary | Dumfries | Scotland |
| United Kingdom | Ninewells Hospital | Dundee | Scotland |
| United Kingdom | Ulster Hospital | Dundonald | Belfast |
| United Kingdom | St Margaret's Hospital | Epping | Essex |
| United Kingdom | Royal Devon and Exeter Hospital | Exeter | |
| United Kingdom | Frimley Park Hospital | Frimley | |
| United Kingdom | Medway Maritime Hospital | Gillingham | Kent |
| United Kingdom | Western Infirmary | Glasgow | |
| United Kingdom | Cheltenham General Hospital | Gloucester | Gloucs |
| United Kingdom | Grantham and District Hospital | Grantham | Lincolnshire |
| United Kingdom | Royal Surrey County Hospital | Guildford | |
| United Kingdom | Harrogate District Hospital | Harrogate | North Yorkshire |
| United Kingdom | Withybush General Hospital | Haverfordwest | Wales |
| United Kingdom | Hereford County Hospital | Hereford | |
| United Kingdom | Wycombe General Hospital | High Wycombe | England |
| United Kingdom | Huddersfield Royal Infirmary | Huddersfield | |
| United Kingdom | Ipswich Hospital | Ipswich | |
| United Kingdom | Airedale General Hospital | Keighley | England |
| United Kingdom | Kidderminster Hospital | Kidderminster | England |
| United Kingdom | Kingston Hospital | Kingston Upon Thames | Surrey |
| United Kingdom | Leeds General Infirmary/ St James' University Hospital | Leeds | |
| United Kingdom | University Hospitals of Leicester NHS Trust | Leicester | |
| United Kingdom | University Hospital, Lewisham | Lewisham | London |
| United Kingdom | Lincoln County Hospital | Lincoln | |
| United Kingdom | Royal Liverpool University Hospital | Liverpool | |
| United Kingdom | Prince Philip Hospital | Llanelli | Carmarthenshire |
| United Kingdom | Charing Cross Hospital | London | |
| United Kingdom | Guy's Hospital | London | England |
| United Kingdom | Homerton University Hospital | London | |
| United Kingdom | King's College Hospital | London | England |
| United Kingdom | Northwick Park Hospital | London | |
| United Kingdom | Royal Free Hospital | London | England |
| United Kingdom | Royal Marsden - London | London | England |
| United Kingdom | St Bartholomew's Hospital | London | |
| United Kingdom | St. Mary's Hospital | London | England |
| United Kingdom | Whittington Hospital | London | England |
| United Kingdom | Luton and Dunstable Hospital | Luton | |
| United Kingdom | Macclesfield District General Hospital | Macclesfield | |
| United Kingdom | Maidstone Hospital | Maidstone | |
| United Kingdom | North Manchester General Hospital - Penine Actute Hospitals Trust | Manchester | England |
| United Kingdom | Wythenshawe Hospital | Manchester | England |
| United Kingdom | Hillingdon Hospital | Middlesex | |
| United Kingdom | Milton Keynes General Hospital | Milton Keynes | |
| United Kingdom | Royal Victoria Infirmary | Newcastle | Newcastle-Upon-Tyne |
| United Kingdom | North Tyneside Hospital | North Shields | England |
| United Kingdom | Northampton General Hospital NHS Trust | Northampton | England |
| United Kingdom | Norfolk and Norwich University Hospital | Norwich | |
| United Kingdom | Nottingham City Hospital | Nottingham | |
| United Kingdom | George Eliot Hospital | Nuneaton | England |
| United Kingdom | Royal Oldham Hospital | Oldham | England |
| United Kingdom | Princess Royal University Hospital | Orpington | Kent |
| United Kingdom | Derriford Hospital | Plymouth | |
| United Kingdom | Dorset County Hospital | Poole | |
| United Kingdom | Poole Hospital | Poole Dorset | England |
| United Kingdom | Neath Port Talbot Hospital | Port Talbot | West Glamorgan |
| United Kingdom | Craigavon Area Hospital | Portadown | Co.Amagh |
| United Kingdom | Royal Berkshire Hospital | Reading | England |
| United Kingdom | East Surrey Hospital | Redhill | Surrey |
| United Kingdom | North Wales CTC, Glan Clwyd Hospital | Rhyl | Wales |
| United Kingdom | Queen's Hospital, | Romford | |
| United Kingdom | Rotherham District General Hospital | Rotherham | South Yorkshire |
| United Kingdom | Salford Royal Hospital | Salford | |
| United Kingdom | Salisbury District Hospital | Salisbury | |
| United Kingdom | Weston Park Hospital | Sheffield | |
| United Kingdom | Heatherwood and Wexham Park Hospitals NHS trust | Slough | Berkshire |
| United Kingdom | Ealing Hospital | Southall | Middlesex |
| United Kingdom | Southampton General Hospital | Southampton | |
| United Kingdom | St Albans City Hospital | St Albans | Hertfordshire |
| United Kingdom | Staffordshire General Hospital | Stafford | |
| United Kingdom | Stepping Hill Hospital | Stockport | |
| United Kingdom | University Hospital of North Tees | Stockton-on-Tees | |
| United Kingdom | University Hospital of North Staffordshire | Stoke-On-Trent | England |
| United Kingdom | Royal Marsden Hosital, | Sutton | England |
| United Kingdom | Singleton Hospital | Swansea | Wales |
| United Kingdom | Musgrove Park Hospital | Taunton | |
| United Kingdom | Princess Royal Hospital | Telford | Shropshire |
| United Kingdom | St George's Hospital, | Tooting | |
| United Kingdom | Torbay District General Hospital | Torquay | |
| United Kingdom | Royal Cornwall Hospital | Truro | |
| United Kingdom | Tunbridge Wells Hospital | Tunbridge Wells | Kent |
| United Kingdom | Mid Yorkshire Hospitals | Wakefield | |
| United Kingdom | Warwick Hospital | Warwick | |
| United Kingdom | Queen Elizabeth II Hospital | Welwyn Garden City | Hertfordshire |
| United Kingdom | Southend NHS Trust Hospital | Westcliff-On-Sea | England |
| United Kingdom | Weston General Hospital, Avon | Weston-Super-Mare | Somerset |
| United Kingdom | Royal Albert Edward Infirmary | Wigan | |
| United Kingdom | Royal Hampshire County Hospital | Winchester | England |
| United Kingdom | New Cross Hospital | Wolverhampton | England |
| United Kingdom | Queen Elizabeth Hospital | Woolwich | London |
| United Kingdom | Worcester Royal Hospital | Worcester | England |
| United Kingdom | Worthing Hospital | Worthing | |
| United Kingdom | Yeovil District Hospital | Yeovil | England |
| Lead Sponsor | Collaborator |
|---|---|
| Institute of Cancer Research, United Kingdom |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. | 5 years post-randomisation | |
| Secondary | Time to local recurrence | 5 years post-randomisation | ||
| Secondary | Time to distant recurrence | 5 years post-randomisation | ||
| Secondary | Overall Survival | 5 years post-randomisation | ||
| Secondary | Breast cancer free survival | 5 years post-randomisation | ||
| Secondary | 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. | At time of surgery (around 2 weeks post-randomisation) | |
| Secondary | Gene expression profile | At time of surgery (around 2 weeks post-randomisation) |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
| Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
| Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
| Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
| Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
| Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
| Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
| Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
| Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
| Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
| Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
| Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
| Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
| Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
| Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
| Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
| Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
| Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A |