Procedures
PD, breast cancer
PRIMARY TUMOR, BREAST CANCER
During the preoperative period, eligible patients started a 24–28-week course of NET comprising once daily oral intake of 2.5 mg/day LET, within 4 weeks after enrollment. The clinical response to LET was evaluated at 1, 2, and 4 months after the start of the treatment by clinical examination and ultrasonography (US), and at the conclusion of treatment at 6 months by clinical examination, US, and either computed tomography or magnetic resonance imaging (MRI). The clinical response evaluation was only done for the primary tumor, and not for the lymph node area. If PD was identified, LET was discontinued and patients were treated and followed up in accordance with the pre-determined procedures.Surgery for breast cancer was performed 1–4 weeks after the completion of NET. Patients who were eligible in the postoperative period were randomized to receive either CT followed by LET (CT+ET group) or LET alone (ET group) at a 1:1 ratio within 4 weeks after postoperative enrollment for 4.5–5 years. The treatment regimen for LET in both groups was the same as the regimen during the preoperative period.