The PRIME Breast Cancer Trial: Postoperative Radiotherapy in Minimum-Risk Elderly

ISRCTN	ISRCTN14817328
DOI	https://doi.org/10.1186/ISRCTN14817328
Protocol serial number	HTA 96/03/01
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

Submission date: 19/08/2002
Registration date: 19/08/2002
Last edited: 17/10/2018

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/radiotherapy-after-surgery-for-breast-cancer-for-women-over-65-years-old

Contact information

Dr Linda Williams
Scientific

PRIME Administrator
Medical Statistics Unit
Medical School
Teviot Place
Edinburgh
EH8 9AG
United Kingdom

Phone	+44 (0)131 651 1631
Email	linda.williams@ed.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The PRIME Breast Cancer Trial: Postoperative Radiotherapy in Minimum-Risk Elderly
Study acronym	PRIME I
Study objectives	To assess whether the omission of post-operative radiotherapy in women with low risk axillary node negative breast cancer (T0-2) treated by breast conservation with wide local excision and endocrine therapy: 1. Improves quality of life 2. Is more cost-effective
Ethics approval(s)	Added as of 23/08/2007: Multicentre Research Ethics Committee (MREC) approval was granted by the Scotland Committee on 15 October 1998.
Health condition(s) or problem(s) studied	Breast cancer
Intervention	Please note that, as of 10 January 2008, the anticipated start and end dates of this trial have been updated from 1 September 1999 and 31 December 2003 to 1 January 1999 and 30 November 2005, respectively. Interventions: Patients treated by conservation surgery and adjuvant endocrine therapy will be randomised to receive or not to receive breast irradiation See details of PRIME II trial on http://www.controlled-trials.com/ISRCTN95889329
Intervention type	Other
Primary outcome measure(s)	1. Quality of life assessed by: i. EORTC QLQ-C30 and QLQ-BR23 ii. Philadelphia Geriatric Center Morale Scale iii. EuroQol 2. Anxiety and depression assessed by the Hospital Anxiety and Depression Scale 3. Cost-effectiveness
Key secondary outcome measure(s)	1. Loco-regional and distant recurrence rate 2. Functional status assessed by Clackmannan and Barthel scales 3. Acute and late morbidity assessed by the RTOG/EORTC SOMA scale 4. Cosmesis assessed by the Harris scale and the Van Limbergen scale
Completion date	30/11/2005

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Female
Target sample size at registration	255
Key inclusion criteria	1. Age of 65 years or more, receiving adjuvant endocrine therapy 2. Medically suitable to attend for all treatments and follow ups 3. Histologically confirmed unilateral breast cancer of Tumour, Metastasis, Node (TMN) stages T0-2 4. No axillary node involvement on histological assessment 5. Had breast conserving surgery with complete excision on histological assessment 6. Able and willing to give informed consent
Key exclusion criteria	1. Past history of pure in situ carcinoma of either breast or previous or concurrent malignancy within the past five years other than non-melanomatous skin cancer or carcinoma in situ of cervix 2. Grade III cancer with lymphatic/vascular invasion (because of higher risk of local recurrence)
Date of first enrolment	01/01/1999
Date of final enrolment	30/11/2005

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

PRIME Administrator

Edinburgh
EH8 9AG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2007		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results				No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

17/10/2018: Cancer Research UK lay results summary link added to Results (plain English)