Breast cancer Cancer Breast
Conditions
Interventions
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, respecti
Sponsors
Department of Health (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed