A study to help understand the outcomes of pre-surgical treatment for breast cancer

ISRCTN	ISRCTN11160072
DOI	https://doi.org/10.1186/ISRCTN11160072
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Queen's University of Belfast
Funder	Association of Breast Surgery

Submission date: 05/06/2019
Registration date: 10/06/2019
Last edited: 01/03/2021

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
The use of treatment such as chemotherapy or hormonal therapy before surgery in women with early breast cancer has been shown to reduce the size of breast tumours, and potentially therefore reduce the amount of surgery required to treat these patients.

However, there appears to be variation in both how often these treatments are used across the UK, and in how decisions are made about surgery following treatment. The NeST study plans to carry out a national survey of practice, to see which patients are being treated with chemotherapy and hormone therapy before an operation. The study will look to see how patients are being followed up, to see if their breast cancer is getting smaller in response to treatment, and will see how many patients treated in this way in the UK have a cancer with disappears completely after treatment. We will also look to see how decisions are made about surgery after this treatment

Who can participate?
Participants in this study have been diagnosed with breast cancer and will be receiving standard treatment with medical therapy (either chemotherapy, endocrine therapy or targeted therapy)

What does the study involve?
The study is taking place in a number of breast units across the UK. It involves only the collection of anonymous information on women with breast cancer receiving standard treatment before surgery, and there is no change to treatment as a result of the study.

What are the possible benefits and risks of participating?
This study will provide information to guide future decision-making, and will allow us to ascertain best practice in this area

Where is the study run from?
Centre for Cancer Research & Cell Biology
Queen's University Belfast

When is the study starting and how long is it expected to run for?
The NeST Study will run from December 2017 for approximately 2 years, to allow data collection to be completed on all patients starting treatment between December 2017 and December 2018

Who is funding the study?
The study is funded by the Association of Breast Surgery.

Who is the main contact?
Mr Stuart McIntosh,
s.mcintosh@qub.ac.uk

Contact information

Mr Stuart McIntosh
Public

Centre for Cancer Research & Cell Biology
Queen's University Belfast
Belfast
BT9 7AE
United Kingdom

ORCID ID	0000-0002-4123-9611
Phone	02890972986
Email	s.mcintosh@qub.ac.uk

Study information

Primary study design	Observational
Study design	Multi-centre prospective observational cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Neoadjuvant systemic therapy in breast cancer: a national prospective multicentre audit of neoadjuvant systemic therapy in breast cancer
Study acronym	NeST
Study objectives	Neoadjuvant systemic therapies (NST) are increasingly used to treat breast cancer in the UK. However, there is a lack of high-quality data surrounding indications for use and access, short-term outcomes and surgical decision-making following NST. This study aims to document these with a view to establishing current UK practice in this area.
Ethics approval(s)	The NeST study does not require ethical approval because they involve the routine collection of clinical outcome data, and this has been agreed with host organisations.
Health condition(s) or problem(s) studied	Breast cancer
Intervention	Participants in this study have been diagnosed with breast cancer, and will be receiving standard treatment with medical therapy (either chemotherapy, endocrine therapy or targeted therapy). Data will be collected on baseline tumour characteristics and response to treatment. Participants will then proceed to receive standard surgical treatment. Anonymised data will be collected on the operations performed, response to pre-operative treatment and surgical complications up to 30 days post-surgery. The duration of follow-up will vary according to the length of pre-surgical treatment but will be at least 6 months and should not be more than 12 months for any one patient.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	1. Investigate variation in practice in the use of neoadjuvant systemic therapy in the UK Measurement – percentage of patients being treated with neoadjuvant chemotherapy and endocrine therapy and tumour molecular subtypes. Timepoint – baseline (at diagnosis). 2. Assess surgical practice following neoadjuvant therapy Measurement – percentage of patients having mastectomy/breast conserving surgery. Timepoint – after completion of neoadjuvant therapy 3. Determine pathological response rates after neoadjuvant therapy in current UK practice Measurement – pathological complete response rate reported in all patients. Timepoint – after completion of neoadjuvant therapy.
Key secondary outcome measure(s)	1. Explore the stated indications for the use of neoadjuvant systemic therapy in the UK Measurement – indications given by multidisciplinary team for choice of treatment. Timepoint – baseline 2. Examine treatment regimens in common use Measurement – prescribed treatment regimens for neoadjuvant therapy. Timepoint – at commencement of standard therapy. 3. Investigate how response to neoadjuvant therapy for breast cancer is assessed and reported across the UK. Measurement – number of patients having imaging during therapy. Timepoints – mid-treatment and at completion of treatment 4. Investigate surgical management of the axilla following neoadjuvant therapy Measurement – percentage of patients have sentinel node biopsy and axillary node clearance before and after neoadjuvant therapy. Timepoints – at start of treatment and after completion of neoadjuvant treatment.
Completion date	30/11/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	1000
Total final enrolment	1283
Key inclusion criteria	1. Age > 16 years 2. Histologically confirmed diagnosis of breast cancer 3. MDT recommended treatment of neoadjuvant systemic therapy (either hormonal or chemotherapy) - including patients entering into clinical trials of neoadjuvant systemic therapy.
Key exclusion criteria	1. Patients entering “window of opportunity” clinical trials
Date of first enrolment	01/12/2017
Date of final enrolment	30/11/2018

Locations

Countries of recruitment

United Kingdom
England
Northern Ireland
Scotland
Wales

Study participating centres

Belfast City Hospital

Lisburn Road
Belfast
BT9 7AB
United Kingdom

Aberdeen Royal Infirmary

Foresterhill Health Campus, Foresterhill Road
Aberdeen
AB25 2ZN
United Kingdom

Airedale NHS Foundation Trust

Skipton Road
Keighley
BD20 6TD
United Kingdom

Betsi Calwaladr University Health Board

Ysbyty Gwynedd, Penrhosgarnedd
Bangor
LL57 2PW
United Kingdom

Bradford Teaching Hospitals NHS Foundation Trust

Bradford Royal Infirmary, Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Southmead Hospital Bristol

Southmead Road, Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

St Helens and Knowsley Teaching Hospitals

Burney Breast Unit, St Helens Hospital, Marshalls Cross Road
St Helens
WA9 3DA
United Kingdom

Cambridge University Hospitals NHS Foundation Trust

Addenbrooke's Hospital, Cambridge Biomedical Campus, Hills Road
Cambridge
CB2 0QQ
United Kingdom

Birmingham City Hospital

Dudley Road
Birmingham
B18 7QH
United Kingdom

Doncaster Royal Infirmary

Armthorpe Road
Doncaster
DN2 5LT
United Kingdom

Glasgow Royal Infirmary

84 Castle Street
Glasgow
G4 0SF
United Kingdom

Hampshire Hospitals NHS Foundation Trust

Royal Hampshire County Hospital, Romsey Road
Winchester
SO22 5DG
United Kingdom

University Hospitals Birmingham NHS Foundation Trust

Mindelsohn Way, Edgbaston
Birmingham
B15 2GW
United Kingdom

Homerton University Hospital

Homerton Row
London
E9 6SR
United Kingdom

St James's Hospital

Beckett Street
Leeds
LS8 7TF
United Kingdom

Glenfield Hospital

Groby Road
Leicester
LE3 9QP
United Kingdom

Wythenshawe Hospital

Southmoor Road, Wythenshawe
Manchester
M23 9LT
United Kingdom

Milton Keynes University Hospital

Standing Way, Eagleston
Milton Keynes
MK5 6LD
United Kingdom

Royal Victoria Infirmary

Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Ninewells Hospital

James Arrott Drive
Dundee
DD2 1SY
United Kingdom

Altnagelvin Hospital

Glenshane Road
Londonderry
BT47 6SB
United Kingdom

Nottingham University Hospitals NHS Trust - Breast Institute

Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Queen Alexandra Hospital

Portsmouth
PO6 3LY
United Kingdom

Royal Preston Hospital

Sharoe Green Lane, Fulton
Preston
PR2 9HT
United Kingdom

Royal Devon and Exeter Hospital

Barrack Road
Exeter
EX2 5DW
United Kingdom

Royal Liverpool University Hospital

Prescot Street
Liverpool
L7 8XP
United Kingdom

Royal Marsen Hospital

Downs Road
Sutton
SM2 5PT
United Kingdom

Royal Stoke University Hospital

Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom

Royal Surrey County Hospital

Egerton Road
Guildford
GU2 7XX
United Kingdom

Salisbury District Hospital

Odstock Road
Salisbury
SP2 8BJ
United Kingdom

Sheffield Teaching Hospitals NHS Trust

Royal Hallamshire Hospitals, Glossop Road
Sheffield
S10 2JF
United Kingdom

Ulster Hospital Dundonald

Upper Newtonards Road, Dundonald
Belfast
BT16 1RH
United Kingdom

Southampton General Hospital

Tremona Road
Southampton
SO16 6YD
United Kingdom

Warrington and Halton Hospitals NHS Foundation Trust

Lovely Lane
Warrington
WA6 1QG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Stuart McIntosh (s.mcintosh@qub.ac.uk). De-identified raw participant level data (on baseline tumour characteristics, treatment regimens, and short-term outcomes) will be made available once the study is complete, the primary analysis has been carried out and the initial results published. Requests for access to the data will be reviewed by the NeST Study Steering Group prior to any data sharing.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	11/11/2019	06/01/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

01/03/2021: Internal review.
11/06/2020: The total final enrolment number has been added.
06/01/2020: Publication reference added.
05/08/2019: Internal review.
10/06/2019: Trial’s existence confirmed by Association of breast surgery