Condition category
Cancer
Date applied
30/01/2017
Date assigned
07/03/2017
Last edited
11/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Miss Natalie Atkins

ORCID ID

Contact details

Sir Richard Doll Building
15 Cotswold Road
Sutton
Surrey
SM2 5NG
United Kingdom
+44 208 722 4054
primetime-icrctsu@icr.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

33217

Study information

Scientific title

Post-operative avoidance of radiotherapy: biomarker selection of women categorised to be in a very low risk group by IHC4+C

Acronym

PRIMETIME

Study hypothesis

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

East of England – Cambridgeshire and Hertfordshire Research Ethics Committee, 05/09/2016, ref: 16/EE/0305

Study design

Non-randomised; Interventional; Design type: Treatment, Radiotherapy, Management of Care

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Cancer, Primary sub-specialty: Breast Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasm of breast

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.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Ipsilateral breast local relapse rate 5 years from study registration is assessed through patient note review.

Secondary outcome measures

1. Ipsilateral breast local relapse rate is measured by patient note review 10 years from study registration
2. Regional relapse rate is measured by patient note reviewat 5 and 10 years
3. Distant relapse rate is measured by patient note review at 5 and 10 years
4. Overall survival is measured by patient note review at 5 and 10 years
5. Breast cancer specific survival is measured by patient note review at 5 and 10 years

Overall trial start date

01/07/2015

Overall trial end date

17/03/2040

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 2400; UK Sample Size: 2400

Participant 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

Recruitment start date

17/03/2017

Recruitment end date

17/03/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

Raigmore Hospital
Old Perth Road
Inverness
IV2 3UJ
United Kingdom

Trial participating centre

Wrexham Maelor
Cresnewydd Road
Wrexham
LL13 7TD
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospital
Colney Lane
Norwich
NR4 7UY
United Kingdom

Trial participating centre

Barts Hospital
W Smithfield
London
EC1A 7BE
United Kingdom

Trial participating centre

Royal Free Hospital
Pond Street
London
NW3 2QG
United Kingdom

Trial participating centre

Mount Vernon Hospital
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom

Trial participating centre

Lister Hospital
Coreys Mill Lane,
Stevenage
SG1 4AB
United Kingdom

Trial participating centre

Queen Elizabeth II Hospital
Howlands
Welwyn Garden City
AL7 4HQ
United Kingdom

Trial participating centre

Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Trial participating centre

University Hospital of South Manchester
Southmoor Road, Wythenshawe
Manchester
M23 9LT
United Kingdom

Trial participating centre

Churchill Hospital
Old Road, Headington
Oxford
OX3 7LE
United Kingdom

Trial participating centre

The Hillingdon Hospital
Pield Heath Road
Uxbridge
UB8 3NN
United Kingdom

Trial participating centre

Clatterbridge Cancer Centre
Clatterbridge Health Park, Clatterbridge Road, Birkenhead
Wirral
CH63 4JY
United Kingdom

Trial participating centre

The Royal Marsden
203 Fulham Road
London
SW3 6JJ
United Kingdom

Trial participating centre

The Royal Marsden
Downs Road
Sutton
SM2 5PT
United Kingdom

Trial participating centre

The Royal Bournemouth Hospital
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom

Trial participating centre

Royal Glamorgan Hospital
Ynysmaerdy
Llantrisant
CF72 8XR
United Kingdom

Trial participating centre

Musgrove Park Hospital
Parkfield Drive
Taunton
TA1 5DA
United Kingdom

Trial participating centre

West Suffolk Hospital
Hardwick Lane
Bury Saint Edmunds
IP33 2QZ
United Kingdom

Sponsor information

Organisation

Institute of Cancer Research

Sponsor details

Royal Cancer Hospital
237 Fulham Road
London
SW3 6JB
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

17/03/2041

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/08/2017: Cancer Help UK lay summary link added. 06/06/2017: Internal review