Trial of PeriOperative Endocrine Therapy - Individualising Care

ISRCTN	ISRCTN63882543
DOI	https://doi.org/10.1186/ISRCTN63882543
EudraCT/CTIS number	2007-003877-21
ClinicalTrials.gov number	NCT02338310
Secondary identifying numbers	ICR-CTSU/2007/10015

Submission date: 25/10/2007
Registration date: 18/12/2007
Last edited: 31/03/2021

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-of-a-short-course-of-hormone-therapy-before-and-after-surgery-for-early-breast-cancer

(updated 31/03/2021, previously:
http://www.cancerhelp.org.uk/trials/a-trial-of-a-short-course-of-hormone-therapy-before-and-after-surgery-for-early-breast-cancer)

Contact information

Mrs Jane Banerji
Scientific

Clinical Trial Coordinator
ICR Clinical Trials & Statistics Unit (ICR-CTSU)
Section of Clinical Trials
The Institute of Cancer Research
Sir Richard Doll Building
Cotswold Road
Sutton
SM2 5NG
United Kingdom

Phone	+44 208 722 4297/4013
Email	poetic-icrctsu@icr.ac.uk

Study information

Study design	Randomised phase III open-label clinical trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Trial of PeriOperative Endocrine Therapy - Individualising Care
Study acronym	POETIC
Study hypothesis	1. That peri-operative endocrine therapy with an aromatase inhibitor for two weeks before and after surgery (perioperative therapy) followed by standard adjuvant therapy improves outcome compared with standard therapy alone in postmenopausal women with hormone receptor positive breast cancer 2. That the proliferation marker Ki67 as measured by Immunohistochemistry (IHC) in the excised cancer around 2 weeks after starting aromatase inhibitor therapy will predict for relapse free survival (Disease-Free Survival [DFS]) more effectively than the pre-treatment Ki67 value in the individual patient Please note that as of 07/05/2008, the anticipated start and end dates of this trial were updated. The previous anticipated start and end dates were 01/02/2008 and 01/05/2011 respectively. Please note that as of 10/10/2012, the anticipated end date for this trial was updated from 01/10/2011 to 01/02/2013
Ethics approval(s)	South East Research Ethics Committee on 16/04/2008 (ref: 08/H1102/37).
Condition	Early breast cancer
Intervention	Patients will be randomised in the ratio of 2:1 to receive anastozole 1 mg or letrozole 2.5 mg daily, taken orally for 4 weeks, commencing 2 weeks before surgery for primary breast cancer. Patients will be followed up long term, i.e., at least 5 years to satisfy primary endpoint of relapse free survival. The Royal Marsden NHS Foundation Trust is a co-sponsor of this trial.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Anastrozole, letrozole
Primary outcome measure	Current primary outcome measures as of 11/10/2012: Relapse free survival (clinical endpoint) Previous primary outcome measures until 11/10/2012: 1. 5-year relapse free survival, planned for mid-2016 2. Proliferation rate (Ki67) at baseline core biopsy, and at surgical excision (both groups) to determine the relative accuracy of baseline and 2 week Ki67 in predicting outcome using pre-treatment and on-treatment values
Secondary outcome measures	Current secondary outcome measures as of 11/10/2012: 1. Time to local recurrence 2. Time to distant recurrence 3. Overall survival, planned for mid-2016 4. Gene expression profile at core biopsy and at surgical excision (both groups) to determine the relative accuracy of baseline and 2 week profiles in predicting outcome with pre-treatment and on-treatment 5. Proliferation rate (Ki67) at baseline core biopsy, and at surgical excision (biological endpoint) Previous secondary outcome measures until 11/10/2012: 1. Time to local recurrence 2. Time to distant recurrence 3. Overall survival, planned for mid-2016 4. Gene expression profile at core biopsy and at surgical excision (both groups) to determine the relative accuracy of baseline and 2 week profiles in predicting outcome with pre-treatment and on-treatment
Overall study start date	01/08/2008
Overall study end date	01/08/2028

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	4000
Participant inclusion criteria	1. Postmenopausal women with core biopsy-proven hormone receptor positive invasive breast cancer. Postmenopausal is defined as a woman fulfilling any one of the following criteria: 1.1. Aged greater than 50 years with amenorrhoea greater than 12 months and an intact uterus 1.2. Has undergone a bilateral oophorectomy 1.3. In women who have undergone a hysterectomy, then Follicle Stimulating Hormone (FSH) levels within the postmenopausal range (utilising ranges from the testing laboratory facility) are required if the patient is aged less than 55 years 1.4. In women who have been on Hormone Replacement Therapy (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 less than 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 minimum size, or a tumour with an ultrasound size of at least 1.5 cm 5. World Health Organization (WHO) performance status of 0, 1, or 2 6. Written informed consent to participate in the trial and to donation of tissue (fresh tissue and surplus tissue from diagnostic procedures)
Participant exclusion criteria	Current exclusion criteria as of 11/10/2012: 1. Locally advanced/inoperable breast cancer 2. Evidence of metastatic disease 3. Concurrent use of HRT 4. Prior endocrine therapy for breast cancer 5. Neoadjuvant chemotherapy 6. Any invasive malignancy within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ) 7. Any severe coincident medical disease or inability to give informed consent 8. Treatment with a non-approved or investigational drug within 4 weeks before randomisation 9. Previous invasive breast cancer or bilateral breast cancer (surgically treated DCIS or LCIS allowed) 10. Previous use of oestrogen implants at ANY time 11. Continuous long term systemic steroid usage Previous exclusion criteria until 11/10/2012: 1. Locally advanced/inoperable breast cancer 2. Evidence of metastatic disease 3. Concurrent use of HRT 4. Prior endocrine therapy for breast cancer 5. Neoadjuvant chemotherapy 6. Any invasive malignancy within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ) 7. Any severe coincident medical disease or inability to give informed consent 8. Treatment with a non-approved or investigational drug within 4 weeks before randomisation
Recruitment start date	01/08/2008
Recruitment end date	17/04/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

The Institute of Cancer Research

Sutton
SM2 5NG
United Kingdom

Sponsor information

Institute of Cancer Research (UK)
Research organisation

123 Old Brompton Road
London
SW7 3RP
United Kingdom

Phone	+44 20 7352 8133
Email	R&D-CCR@rmh.nhs.uk
Website	http://www.icr.ac.uk/
"ROR"	https://ror.org/043jzw605

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) (ref: C1491/A8671)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date	31/12/2019
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal in late 2019.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Jane Banerji (poetic-icrctsu@icr.ac.uk).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Interim results article	interim results	31/12/2019	02/01/2019	Yes	No
Plain English results			31/03/2021	No	Yes

Editorial Notes

31/03/2021: Added CRUK link to plain English results.
02/01/2019: Publication reference added.
16/09/2019: Publication and dissemination plan and IPD sharing statement added.
10/09/2019: ClinicalTrials.gov number added.
07/08/2019: The following changes were made to the trial record:
1. Contact details updated.
2. EudraCT number added.
3. The recruitment end date was changed from 01/02/2013 to 17/04/2014.
4. The overall trial end date was changed from 01/02/2013 to 01/08/2028.
03/05/2016: No publications found, verifying study status with principal investigator.