A study to help understand the outcomes of pre-surgical treatment for breast cancer
| ISRCTN | ISRCTN11160072 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11160072 |
- 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
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
Public
Centre for Cancer Research & Cell Biology
Queen's University Belfast
Belfast
BT9 7AE
United Kingdom
 ORCID ID |
0000-0002-4123-9611 |
|---|---|
| Phone | 02890972986 |
| s.mcintosh@qub.ac.uk |
Study information
| Study design | Multi-centre prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 01/12/2017 |
| Completion date | 30/11/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1,000 |
| 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
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Belfast
BT9 7AB
United Kingdom
Aberdeen
AB25 2ZN
United Kingdom
Keighley
BD20 6TD
United Kingdom
Bangor
LL57 2PW
United Kingdom
Bradford
BD9 6RJ
United Kingdom
Bristol
BS10 5NB
United Kingdom
St Helens
WA9 3DA
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Birmingham
B18 7QH
United Kingdom
Doncaster
DN2 5LT
United Kingdom
Glasgow
G4 0SF
United Kingdom
Winchester
SO22 5DG
United Kingdom
Birmingham
B15 2GW
United Kingdom
London
E9 6SR
United Kingdom
Leeds
LS8 7TF
United Kingdom
Leicester
LE3 9QP
United Kingdom
Manchester
M23 9LT
United Kingdom
Milton Keynes
MK5 6LD
United Kingdom
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Dundee
DD2 1SY
United Kingdom
Londonderry
BT47 6SB
United Kingdom
Nottingham
NG5 1PB
United Kingdom
PO6 3LY
United Kingdom
Preston
PR2 9HT
United Kingdom
Exeter
EX2 5DW
United Kingdom
Liverpool
L7 8XP
United Kingdom
Sutton
SM2 5PT
United Kingdom
Stoke-on-Trent
ST4 6QG
United Kingdom
Guildford
GU2 7XX
United Kingdom
Salisbury
SP2 8BJ
United Kingdom
Sheffield
S10 2JF
United Kingdom
Belfast
BT16 1RH
United Kingdom
Southampton
SO16 6YD
United Kingdom
Warrington
WA6 1QG
United Kingdom
Sponsor information
University/education
University Road
Belfast
BT7 1NN
Northern Ireland
United Kingdom
| Phone | 02890245133 |
|---|---|
| researchgovernance@qub.ac.uk | |
| Website | http://qub.ac.uk |
"ROR" |
https://ror.org/00hswnk62 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | This protocol will be disseminated through the Mammary Fold Academic Research Collaborative (MFAC), the Reconstructive Surgery Trials Network, the Association of Breast Surgery, the British Association of Plastic, Reconstructive and Aesthetic Surgeons and others. Participating units will have access to their own data and information from individual units will be fed back with a comparison to the national data. National results will be fed back to the appropriate professional associations. Collective results will be analysed and the results presented at relevant scientific meetings and published in appropriate peer-reviewed journals. Results will also be made available to relevant patient advocacy groups such as Independent Cancer Patients’ Voice. Thus, results will be available to aid in the decision-making for women considering NST. |
| 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 |
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
