Post-operative Radiotherapy In Minimum-risk Elderly - Phase II

Not Applicable

Completed

• Conditions: Breast cancer; Cancer; Breast

• Registration Number: ISRCTN95889329
• Lead Sponsor: niversity of Edinburgh (UK)

Brief Summary

2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25637340 results 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36791159/ (added 16/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-17
• Study Completion: 2008-11-30
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1326

Inclusion Criteria

1. Breast conserving surgery with a complete pathological excision margin of all invasive and non invasive cancer (a minimum of 1 mm on histological assessment)
2. Histologically confirmed unilateral breast cancer of pathological size 3 cm or less
3. Oestrogen receptor or progesterone receptor positive and treated with post-operative adjuvant endocrine therapy (patients who have been treated with pre-operative neo-adjuvant endocrine therapy can be included)
4. No axillary node involvement on histological assessment
5. Medically suitable to attend for all treatment and follow up
6. Able and willing to give informed consent

Exclusion Criteria

1. Age younger than 65 years (date of issue of pathology results)
2. Grade III cancer combined with lymphatic/vascular invasion
3. Previous in situ or invasive carcinoma of either breast
4. Current or previous malignancy, within the past 5 years, other than non-melanomatous skin cancer or carcinoma in situ of cervix

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ipsilateral breast cancer recurrence rates

Secondary Outcome Measures

Name	Time	Method
Regional recurrence, contralateral breast cancer, distant metastases, disease free survival and overall survival