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Objective   To evaluate the efficacy and safety of the combination of pegylated liposomal doxorubicin and docetaxel as neoadjuvant therapy for breast cancer (BC) in patients with axillary lymph node metastasis.Methods   In this single-arm study, 91 patients with clinical stage IIA–IIIc breast cancer received six cycles of pegylated liposomal doxorubicin plus docetaxel as neoadjuvant chemotherapy (NAC). Trastuzumab was allowed for patients with human epidermal growth factor receptor 2-positive tumors. The primary endpoint was pathologic complete response (pCR) in the breast after surgery. The overall response rate (ORR), Miller–Payne (MP) score of the primary tumors, and incidence of adverse events were also evaluated.Results   In total, 88 patients completed all cycles of NAC. Fourteen patients (15.4%, 95% confidence interval [CI] = 7.8–22.9) achieved pCR. The ORR was 89% (95% CI = 82.5–95.6), and 72 lesions (79.1%) were rated as MP grade 3 or higher. The left ventricular ejection fraction (LVEF) was within the normal range, although four (4.4%) patients experienced an LVEF decline exceeding 10%. No symptomatic cardiac events were reported.Conclusion   Preoperative NAC with pegylated liposomal doxorubicin and docetaxel appears effective and safe for treating BC with axillary lymph node metastasis.

Combination of pegylated liposomal doxorubicin and docetaxel as neoadjuvant therapy for breast cancer with axillary lymph node metastasis