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

Not Applicable

Completed

• Conditions: Breast cancer; Cancer; Breast

• Registration Number: ISRCTN14817328
• Lead Sponsor: Department of Health (UK)

Brief Summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17669280

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-08-19
• Study Completion: 2005-11-30
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 255

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Quality of life assessed by:<br>i. EORTC QLQ-C30 and QLQ-BR23<br>ii. Philadelphia Geriatric Center Morale Scale<br>iii. EuroQol<br>2. Anxiety and depression assessed by the Hospital Anxiety and <br>Depression Scale<br>3.Cost-effectiveness

Secondary Outcome Measures

Name	Time	Method
1. Loco-regional and distant recurrence rate<br>2. Functional status assessed by Clackmannan and Barthel scales<br>3. Acute and late morbidity assessed by the RTOG/EORTC SOMA scale<br>4. Cosmesis assessed by the Harris scale and the Van Limbergen scale