POETIC: Trial of Perioperative Endocrine Therapy - Individualising Care

• Sponsor: Institute of Cancer Research, United Kingdom (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02338310
• Collaborator: (none)
• Enrollment: 4,486
• Locations: 128
• Arms: 2
• Duration (Months): 307
• Patients Per Site: 35
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Aromatase Inhibitors	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 4486 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Sep 1, 2008
• Anticipated Primary Completion Date: Apr 1, 2024
• Anticipated Study Completion Date: Apr 1, 2034

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: No Aromatase Inhibitor No aromatase inhibitor given around the time of surgery
Experimental: Aromatase Inhibitor Aromatase 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)	Drug: Aromatase Inhibitors; Choice of AI is according to centre policy; any brand can be used; Other Names: Anastrazole Letrozole

Outcome Measures

Primary Outcome Measures

1. Time to recurrence [5 years post-randomisation]

   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.

Secondary Outcome Measures

1. Relapse free survival [5 years post-randomisation]

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

2. Time to local recurrence [5 years post-randomisation]

3. Time to distant recurrence [5 years post-randomisation]

4. Overall Survival [5 years post-randomisation]

5. Breast cancer free survival [5 years post-randomisation]

6. Proliferation rate (Ki67) [At time of surgery (around 2 weeks post-randomisation)]

   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.

7. Gene expression profile [At time of surgery (around 2 weeks post-randomisation)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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:

1. 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.

1. No evidence of metastatic spread by standard assessment according to local guidelines

2. Standard adjuvant endocrine therapy indicated

3. A palpable tumour of any size , or a tumour with an ultrasound size of at least 1.5cm

4. WHO performance status of 0 or 1

5. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ulster Hospital	Dundonald	Belfast	United Kingdom	BT16 1RH
2	Heatherwood and Wexham Park Hospitals NHS trust	Slough	Berkshire	United Kingdom	SL2 4HL
3	Stoke Mandeville Hospital	Aylesbury	Buckinghamshire	United Kingdom	HP21 8AL
4	Prince Philip Hospital	Llanelli	Carmarthenshire	United Kingdom	SA14 8QF
5	Craigavon Area Hospital	Portadown	Co.Amagh	United Kingdom	BT63 5QQ
6	Wansbeck General Hospital	Ashington	England	United Kingdom	NE63 9JJ
7	North Devon District Hospital	Barnstaple	England	United Kingdom	EX31 4JB
8	City Hospital - Birmingham	Birmingham	England	United Kingdom	B18 7QH
9	Royal Blackburn Hospital	Blackburn	England	United Kingdom	BB2 3HH
10	Pilgrim Hospital	Boston	England	United Kingdom	PE21 9QT
11	Bradford Teaching Hospitals NHS Trust, St Luke's Hospital	Bradford	England	United Kingdom	BD5 0NA
12	Burnley General Hospital	Burnley	England	United Kingdom	BB10 2PQ
13	Cumberland Infirmary	Carlisle	England	United Kingdom	CA2 7HY
14	Chelmsford and Essex Centre	Chelmsford	England	United Kingdom	CM2 0QH
15	Chesterfield Royal Hospital	Chesterfield	England	United Kingdom	S44 5BL
16	Countess of Chester Hospital	Chester	England	United Kingdom	CH2 1UL
17	Essex County Hospital	Colchester	England	United Kingdom	C03 3NB
18	Doncaster Royal Infirmary	Doncaster	England	United Kingdom	DN2 5LT
19	Russells Hall Hospital	Dudley	England	United Kingdom	DY1 2HQ
20	Wycombe General Hospital	High Wycombe	England	United Kingdom
21	Airedale General Hospital	Keighley	England	United Kingdom	BD20 6TD
22	Kidderminster Hospital	Kidderminster	England	United Kingdom	DY11 6RJ
23	Whittington Hospital	London	England	United Kingdom	N19 5NF
24	Royal Free Hospital	London	England	United Kingdom	NW3 2QG
25	Guy's Hospital	London	England	United Kingdom	SE1 9RT
26	King's College Hospital	London	England	United Kingdom	SE5 9RS
27	Royal Marsden - London	London	England	United Kingdom	SW3 6JJ
28	St. Mary's Hospital	London	England	United Kingdom	W2 1NY
29	Wythenshawe Hospital	Manchester	England	United Kingdom	M23 9LJ
30	North Manchester General Hospital - Penine Actute Hospitals Trust	Manchester	England	United Kingdom	M8 6RB
31	North Tyneside Hospital	North Shields	England	United Kingdom	NE29 8NH
32	Northampton General Hospital NHS Trust	Northampton	England	United Kingdom	NN6 8BJ
33	George Eliot Hospital	Nuneaton	England	United Kingdom	CV10 7DJ
34	Royal Oldham Hospital	Oldham	England	United Kingdom	OL1 2JH
35	Poole Hospital	Poole Dorset	England	United Kingdom	BH15 2JB
36	Royal Berkshire Hospital	Reading	England	United Kingdom	RG1 5AN
37	University Hospital of North Staffordshire	Stoke-On-Trent	England	United Kingdom	ST4 7LN
38	Royal Marsden Hosital,	Sutton	England	United Kingdom	SM2 5PT
39	Southend NHS Trust Hospital	Westcliff-On-Sea	England	United Kingdom	SS0 0RY
40	Royal Hampshire County Hospital	Winchester	England	United Kingdom	SO22 5DG
41	New Cross Hospital	Wolverhampton	England	United Kingdom	WV10 0QP
42	Worcester Royal Hospital	Worcester	England	United Kingdom	WR5 1DD
43	Yeovil District Hospital	Yeovil	England	United Kingdom	BA21 4AT
44	St Margaret's Hospital	Epping	Essex	United Kingdom	CM16 6TN
45	Cheltenham General Hospital	Gloucester	Gloucs	United Kingdom
46	St Albans City Hospital	St Albans	Hertfordshire	United Kingdom	AL3 5PN
47	Queen Elizabeth II Hospital	Welwyn Garden City	Hertfordshire	United Kingdom	AL7 4HQ
48	Medway Maritime Hospital	Gillingham	Kent	United Kingdom	ME7 5NY
49	Princess Royal University Hospital	Orpington	Kent	United Kingdom	BR6 8ND
50	Tunbridge Wells Hospital	Tunbridge Wells	Kent	United Kingdom	TN2 4QL
51	Grantham and District Hospital	Grantham	Lincolnshire	United Kingdom	NG31 8DG
52	University Hospital, Lewisham	Lewisham	London	United Kingdom	SE13 6LH
53	Queen Elizabeth Hospital	Woolwich	London	United Kingdom	SE18 4QH
54	Ealing Hospital	Southall	Middlesex	United Kingdom	UB1 3HW
55	Royal Victoria Infirmary	Newcastle	Newcastle-Upon-Tyne	United Kingdom	NE1 4LP
56	Harrogate District Hospital	Harrogate	North Yorkshire	United Kingdom	HG2 7SX
57	Belfast City Hospital	Belfast	Northern Ireland	United Kingdom	BT9 7AB
58	Aberdeen Royal Infirmary	Aberdeen	Scotland	United Kingdom	AB25 2ZN
59	Dumfries & Galloway Royal Infirmary	Dumfries	Scotland	United Kingdom	DG1 4AP
60	Ninewells Hospital	Dundee	Scotland	United Kingdom	DD1 9SY
61	Princess Royal Hospital	Telford	Shropshire	United Kingdom	TF1 6TF
62	Weston General Hospital, Avon	Weston-Super-Mare	Somerset	United Kingdom	BS23 4TQ
63	Barnsley District General Hospital	Barnsley	South Yorkshire	United Kingdom	S75 2EP
64	Rotherham District General Hospital	Rotherham	South Yorkshire	United Kingdom	S60 2UD
65	Ashford and St Peter's Hospitals	Chertsey	Surrey	United Kingdom	KT16 0PZ
66	Kingston Hospital	Kingston Upon Thames	Surrey	United Kingdom	KT2 7QB
67	East Surrey Hospital	Redhill	Surrey	United Kingdom	RH1 5RH
68	Bronglais District General Hospital	Aberystwyth	Wales	United Kingdom	SY23 1ER
69	Withybush General Hospital	Haverfordwest	Wales	United Kingdom	SA61 2PZ
70	North Wales CTC, Glan Clwyd Hospital	Rhyl	Wales	United Kingdom	LL18 5UJ
71	Singleton Hospital	Swansea	Wales	United Kingdom	SA 2 8QA
72	Neath Port Talbot Hospital	Port Talbot	West Glamorgan	United Kingdom	SA12 7BX
73	Tameside General Hospital	Ashton-Under-Lyne		United Kingdom
74	Ysbyty Gwynedd	Bangor		United Kingdom
75	Royal United Hospital	Bath		United Kingdom
76	Queen Elizabeth Hospital	Birmingham		United Kingdom
77	Royal Bolton Hospital	Bolton		United Kingdom
78	Royal Bournemouth General Hospital	Bournemouth		United Kingdom
79	Bristol Royal Infirmary	Bristol		United Kingdom
80	Southmead Hospital	Bristol		United Kingdom
81	Addenbrooke's Hospital	Cambridge		United Kingdom
82	East Kent Hospitals	Canterbury		United Kingdom
83	University Hospital Of Wales	Cardiff		United Kingdom
84	Castle Hill Hospital	Cottingham		United Kingdom
85	University Hospital Coventry	Coventry		United Kingdom	CV2 2DX
86	Leighton Hospital	Crewe		United Kingdom
87	Darent Valley Hospital	Dartford		United Kingdom
88	Royal Derby Hospital	Derby		United Kingdom
89	Royal Devon and Exeter Hospital	Exeter		United Kingdom
90	Frimley Park Hospital	Frimley		United Kingdom
91	Western Infirmary	Glasgow		United Kingdom	G11 6NT
92	Royal Surrey County Hospital	Guildford		United Kingdom
93	Hereford County Hospital	Hereford		United Kingdom	HR1 2ER
94	Huddersfield Royal Infirmary	Huddersfield		United Kingdom
95	Ipswich Hospital	Ipswich		United Kingdom
96	Leeds General Infirmary/ St James' University Hospital	Leeds		United Kingdom	LS1 3EX
97	University Hospitals of Leicester NHS Trust	Leicester		United Kingdom	LE3 9QP
98	Lincoln County Hospital	Lincoln		United Kingdom
99	Royal Liverpool University Hospital	Liverpool		United Kingdom
100	Homerton University Hospital	London		United Kingdom	E9 6SR
101	Charing Cross Hospital	London		United Kingdom
102	Northwick Park Hospital	London		United Kingdom
103	St Bartholomew's Hospital	London		United Kingdom
104	Luton and Dunstable Hospital	Luton		United Kingdom
105	Macclesfield District General Hospital	Macclesfield		United Kingdom
106	Maidstone Hospital	Maidstone		United Kingdom
107	Hillingdon Hospital	Middlesex		United Kingdom
108	Milton Keynes General Hospital	Milton Keynes		United Kingdom
109	Norfolk and Norwich University Hospital	Norwich		United Kingdom
110	Nottingham City Hospital	Nottingham		United Kingdom
111	Derriford Hospital	Plymouth		United Kingdom
112	Dorset County Hospital	Poole		United Kingdom
113	Queen's Hospital,	Romford		United Kingdom
114	Salford Royal Hospital	Salford		United Kingdom	M6 8HD
115	Salisbury District Hospital	Salisbury		United Kingdom
116	Weston Park Hospital	Sheffield		United Kingdom
117	Southampton General Hospital	Southampton		United Kingdom
118	Staffordshire General Hospital	Stafford		United Kingdom	ST16 3SA
119	Stepping Hill Hospital	Stockport		United Kingdom
120	University Hospital of North Tees	Stockton-on-Tees		United Kingdom	TS19 8PE
121	Musgrove Park Hospital	Taunton		United Kingdom
122	St George's Hospital,	Tooting		United Kingdom
123	Torbay District General Hospital	Torquay		United Kingdom	TQ2 7AA
124	Royal Cornwall Hospital	Truro		United Kingdom	TR1 3LJ
125	Mid Yorkshire Hospitals	Wakefield		United Kingdom
126	Warwick Hospital	Warwick		United Kingdom	CV34 5BW
127	Royal Albert Edward Infirmary	Wigan		United Kingdom
128	Worthing Hospital	Worthing		United Kingdom

Sponsors and Collaborators

• Institute of Cancer Research, United Kingdom

Investigators

• Principal Investigator: Ian Smith, Professor, Royal Marsden NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institute of Cancer Research, United Kingdom
• ClinicalTrials.gov Identifier: NCT02338310
• Other Study ID Numbers: ICR-CTSU/2007/10015; 2007-003877-21; CRUK/07/015; 08/H1102/37; 63882543; CCR 2973
• First Posted: Jan 14, 2015
• Last Update Posted: Feb 17, 2020
• Last Verified: Feb 1, 2020

• Additional relevant MeSH terms: Letrozole; Aromatase Inhibitors

Study Results

No Results Posted as of Feb 17, 2020