PRIMETIME – Post-operative avoidance of radiotherapy in minimal risk women: patient selection using biomarkers
| ISRCTN | ISRCTN41579286 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41579286 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 190307 |
| Central Portfolio Management System (CPMS) | CPMS 33217 |
| Sponsor | Institute of Cancer Research |
| Funder | Cancer Research UK |
- Submission date
- 30/01/2017
- Registration date
- 07/03/2017
- Last edited
- 27/11/2025
- 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 of protocol
Contact information
Ms Lorna Smith
Public
Public
Sir Richard Doll Building
15 Cotswold Road
Sutton
Surrey
SM2 5NG
United Kingdom
| Phone | +44 208 722 4054 |
|---|---|
| primetime-icrctsu@icr.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomized; Interventional; Design type: Treatment, Radiotherapy, Management of Care |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Post-operative avoidance of radiotherapy: biomarker selection of women categorised to be in a very low risk group by IHC4+C |
| Study acronym | PRIMETIME |
| Study objectives | The aim of this study is to test whether radiotherapy can be safely avoided in a patient population considered to have such a low risk of local recurrence that the potential absolute gain from radiotherapy is so small as to not outweigh the established risks associated with breast radiotherapy. |
| Ethics approval(s) | East of England – Cambridgeshire and Hertfordshire Research Ethics Committee, 05/09/2016, ref: 16/EE/0305 |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | Patients consent and register for pre-screening Ki67 research testing and 5 slides from the diagnostic block are forwarded for analysis to the central laboratory. Breast conserving surgery will proceed according to standard practice. If a patient is confirmed as eligible (meets inclusion and exclusion criteria) they will then be consented for the main PRIMETIME study. The IHC4+C calculator is then utilised to direct treatment according to the patient’s risk category (i.e. if they are deemed ‘very low risk’ they will be recommended to avoid radiotherapy). All patients will then receive either standard breast radiotherapy or no radiotherapy and standard adjuvant hormone therapy and any additional anti-cancer treatments. For patients who receive radiotherapy they will have 5 years of annual mammograms, for patients who do not receive radiotherapy they will be required to attend for 10 years of annual mammograms. Patients will be followed up for 10 years in clinic and thereafter via routine data sources. Added 27/11/2025: Additional Data Linkage Information: Participants from this trial will also be included in the INTERACT project which will link to their data held by NHS England. For more information, please see the INTERACT website: https://www.icr.ac.uk/interact. |
| Intervention type | Other |
| Primary outcome measure(s) |
Ipsilateral breast local relapse rate 5 years from study registration is assessed through patient note review. |
| Key secondary outcome measure(s) |
1. Ipsilateral breast local relapse rate is measured by patient note review 10 years from study registration |
| Completion date | 19/05/2030 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 2400 |
| Key inclusion criteria | 1. Provision of written informed consent to participate in the PRIMETIME study 2. Provision of slides for research testing and availability of KI67 result (contact ICR-CTSU to confirm) 3. Women aged ≥60 years (younger patients are eligible if they are post-menopausal and have co-morbidities that imply a high risk of radiotherapy toxicity e.g. significant cardiovascular disease with left sided breast cancer) 4. Women having had breast conserving surgery with complete resection of tumour tissue (≥1 mm microscopic, circumferential margins of normal tissue from invasive cancer and DCIS) 5. AJCC staging of pT1/pN0/M0 (DCIS is allowed in combination with invasive breast cancer; isolated tumour cells in axillary nodes are allowed) 6. Histological confirmation of grade 1 or 2 invasive breast cancer 7. Oestrogen receptor (ER) positive according to local practice. The H score must be available. 8. Progesterone receptor (PR) positive according to local practice. The percentage positivity must be available. 9. Human epidermal growth factor receptor (HER2) negative according to local practice 10. Patients must be recommended for ≥5 years adjuvant endocrine therapy according to local policy and in the investigator’s opinion, deemed able to comply with the duration of treatment |
| Key exclusion criteria | 1. Patients known to have lymphovascular space invasion and/or axillary nodal micrometastases or macrometastases. 2. Patients with a past history of malignancy excep: 2.1. Basal cell skin cancer and CIN cervix uteri 2.2.Treated, localised squamous cell carcinoma of the skin 2.3. Malignancies treated with curative intent and the patient has been disease free ≥5 years 3. Patients who have had an ipsilateral mastectomy 4. Patients who have received neoadjuvant therapy (endocrine or cytotoxic chemotherapy with therapeutic intent) or who are deemed by the MDT to require adjuvant cytotoxic chemotherapy 5. Patients with mammographically occult breast cancers, ie. present with lump, but not visible on mammogram |
| Date of first enrolment | 17/03/2017 |
| Date of final enrolment | 28/02/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
- Wales
Study participating centres
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
England
Cambridge
CB2 0QQ
England
Raigmore Hospital
Old Perth Road
Inverness
IV2 3UJ
Scotland
Inverness
IV2 3UJ
Scotland
Wrexham Maelor
Cresnewydd Road
Wrexham
LL13 7TD
Wales
Wrexham
LL13 7TD
Wales
Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
England
Norwich
NR4 7UY
England
Barts Hospital
W Smithfield
London
EC1A 7BE
England
London
EC1A 7BE
England
Royal Free Hospital
Pond Street
London
NW3 2QG
England
London
NW3 2QG
England
Mount Vernon Hospital
Rickmansworth Road
Northwood
HA6 2RN
England
Northwood
HA6 2RN
England
Lister Hospital
Coreys Mill Lane
Stevenage
SG1 4AB
England
Stevenage
SG1 4AB
England
Queen Elizabeth II Hospital
Howlands
Welwyn Garden City
AL7 4HQ
England
Welwyn Garden City
AL7 4HQ
England
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
England
London
W6 8RF
England
University Hospital of South Manchester
Southmoor Road
Wythenshawe
Manchester
M23 9LT
England
Wythenshawe
Manchester
M23 9LT
England
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
England
Headington
Oxford
OX3 7LE
England
The Hillingdon Hospital
Pield Heath Road
Uxbridge
UB8 3NN
England
Uxbridge
UB8 3NN
England
Clatterbridge Cancer Centre
Clatterbridge Health Park
Clatterbridge Road
Birkenhead
Wirral
CH63 4JY
England
Clatterbridge Road
Birkenhead
Wirral
CH63 4JY
England
The Royal Marsden
203 Fulham Road
London
SW3 6JJ
England
London
SW3 6JJ
England
The Royal Marsden
Downs Road
Sutton
SM2 5PT
England
Sutton
SM2 5PT
England
The Royal Bournemouth Hospital
Castle Lane East
Bournemouth
BH7 7DW
England
Bournemouth
BH7 7DW
England
Royal Glamorgan Hospital
Ynysmaerdy
Llantrisant
CF72 8XR
Wales
Llantrisant
CF72 8XR
Wales
Musgrove Park Hospital
Parkfield Drive
Taunton
TA1 5DA
England
Taunton
TA1 5DA
England
West Suffolk Hospital
Hardwick Lane
Bury Saint Edmunds
IP33 2QZ
England
Bury Saint Edmunds
IP33 2QZ
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Interim results article | 14/06/2021 | 13/08/2021 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version v3.0 | 03/05/2019 | 16/03/2021 | No | No |
| Protocol file | version 4.0 | 13/01/2021 | 07/11/2023 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN41579286_PROTOCOL_v3.0_03May2019.pdf
- Uploaded 16/03/2021
- ISRCTN41579286_PROTOCOL_V4.0_13Jan21.pdf
- Protocol file
Editorial Notes
27/11/2025: The interventions were updated.
07/11/2023: Protocol file uploaded. Contact details updated.
02/11/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/10/2021 to 28/02/2022.
2. The overall trial end date was changed from 17/03/2040 to 19/05/2030.
3. The intention to publish date was changed from 17/03/2041 to 19/05/2031.
20/09/2021: Internal review.
13/08/2021: Internal review.
17/06/2021: Publication reference added.
16/03/2021: The following changes have been made:
1. The recruitment end date has been changed from 17/03/2021 to 31/10/2021.
2. The trial website has been added.
3. Uploaded protocol version 3.0, 03 May 2019 (not peer reviewed).
28/03/2019: The condition has been changed from "Specialty: Cancer, Primary sub-specialty: Breast Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasm of breast" to "Breast cancer" following a request from the NIHR.
11/08/2017: Cancer Help UK lay summary link added.
06/06/2017: Internal review
