Breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age more than or equal to 18 years 2. Female or male 3. Invasive carcinoma of the breast 4. Breast conservation surgery or mastectomy (reconstruction allowed but not with implant. Tissue expanders with distant metal ports are allowed) 5. Axillary staging and/or dissection 6. Complete microscopic excision of primary tumour 7. Stage pT1-3 pN0-1 M0 disease 8. Written informed consent 9. Able to comply with follow up Concurrent trastuzumab and hormone therapy is allowed
Exclusion criteria
Exclusion criteria: 1. Past history of malignancy except basal cell skin cancer and cervical intraepithelial neoplasia (CIN) or non-breast malignancy allowed if treated with curative intent and at least 5 years disease free 2. Contralateral breast cancer, including ductal carcinoma in-situ (DCIS), irrespective of date of diagnosis 3. Breast reconstruction using implants 4. Concurrent cytotoxic chemotherapy (sequential neoadjuvant or adjuvant cytotoxic therapy allowed) 5. Radiotherapy to any regional lymph node areas (excepting lower axilla included in standard tangential fields to breast/chest wall)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ipsilateral local tumour control: Will be reported at the annual follow up visits. The tests will be performed when the need arises i.e. when the patient feels unwell or reports another lump etc. The tests will be carried out as routine clinical examinations i.e. X rays, computerised tomography (CT) scans, magnetic resonance imaging (MRI), ultrasound. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Early and late adverse effects in normal tissues 2. Quality of life at baseline, 6, months and 2, 5 and 10 years post randomisation 3. Contralateral primary tumours, regional and distant metastases 4. Survival | — |
Countries
England, United Kingdom