The aim of this study was to evaluate the role of surgery in patients who achieve a complete clinical response (cCR) to neoadjuvant chemotherapy for locally advanced breast cancer. A retrospective study of patients with either large central (T2 > 30 mm, N0 or N1, M0) or locally advanced (T3, NO or N1, MO) tumours who received neoadjuvant chemotherapy followed by surgery to the breast and axilla and postoperative radiotherapy. All patients had operable disease at presentation. A total of 133 patients were included. Overall, 43 (32%) patients achieved a cCR following chemotherapy. Of these, 19 patients had no pathological evidence of disease in the breast (pCR) or on imaging or core biopsy and these patients received only adjuvant radiotherapy to the breast. A further 5 patients had no pathological evidence of cancer following breast surgery. 126 patients had an axillary clearance. Increasing response to chemotherapy was related to fewer pathologically involved nodes, but 7 of 24 (29%) patients with a pCR still had evidence of axillary metastases. This is the principal conclusion of the study at the present time. The patients were followed-up for a median of 30 months (range 5-83 months) with a local recurrence rate of 3.8%. There was no difference in either distant recurrence-free or overall survival between patients experiencing a pCR and the remainder. (C) 2002 Elsevier Science Ltd. All rights reserved.