BASO II: a randomised trial for the management of small well-differentiated and special type carcinomas of the breast

INTERVENTION: All patients receive wide local excision of primary tumour. Following surgery patients are randomised to one of four treatment arms: 1. Arm A: Observation only. 2. Arm B: Tamoxifen, 20 mg daily for 5 years or until relapse. 3. Arm C: Radiotherapy only, the radiotherapy technique is at the discretion of the radiotherapist. Suggested fractionations are radiotherapy to the whole breast 40‐50 Gy given in fifteen to twenty‐five fractions followed by a boost to the tumour bed of 10‐15 Gy in five to eight fractions. An iridium of caesium implant is an acceptable alternative. 4. Arm D: Radiotherapy as in Arm C plus tamoxifen, 20 mg daily for 5 years or until relapse. CONDITION: Breast cancer ; Cancer ; Breast PRIMARY OUTCOME: Not provided at time of registration SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: 1. Aged <70 years 2. Unilateral invasive breast carcinoma grade I or of a special type: a. Tubular b. Tubular/cribriform c. Cribriform d. Papillary e. Mucoid f. Not lobular, medullary or other rarer special types of breast carcinoma 3. Tumour size <2 cm 4. No evidence of vascular invasion 5. The histological examination of at least one lymph node is required. There should be no evidence of metastases 6. No distant metastases 7. No other systemic disease 8. No previous invasive malignant disease, except basal cell carcinoma of the skin adequately treated or adequately treated in situ carcinoma of the cervix