A Prospective, Single-Arm, Phase II Trial of Apatinib Combined With Nab-Paclitaxel and Carboplatin for The Neoadjuvant Treatment of Triple-Negative Breast Cancer

Abstract Background: Pathological complete response (pCR) is essential for improvements of prognosis in triple-negative breast cancer (TNBC). We evaluated the efficacy of apatinib combined with nab-paclitaxel and carboplatin in patients in this phase II clinical trial.Methods: Women with hormone receptor- and human epidermal growth factor receptor 2 (HER2)- negative, stage II/III breast cancer received six cycles of 75 mg/m2 docetaxel, carboplatin (AUC = 5) and 15 mg/kg bevacizumab every 21 days. The primary end point was pathological complete response (pCR) in the primary breast and axillary lymph nodes (ALN).Results: Thirty-two patients were recruited into the clinical trial, the vast majority of the patients had stage III tumors (65.6%) and the median longest tumor size was 3.5 cm. The pCR rate was 43.8% (n = 14); clinical response rate 93.8% (n = 30); complete response rate 21.9% (n = 7); partial response rate 71.9% (n = 23); stable disease 6.2% (n = 2). After surgery, 7 (63.6%) of the 11 patients without axillary lymph node metastasis achieved a pCR. The median target lesions in breast reduced to 1.2 cm after the third cycle treatment and 0.9cm after the last cycle. Most frequent grade 3/4 adverse events were thrombopenia (40.6%, n = 13) and neutropenia (25%, n = 8). Conclusions: Neoadjuvant apatinib, combined with albumin paclitaxel and carboplatin resulted in an encouraging pCR rate in locally advanced breast cancer and no major safety concerns during the therapy.Clinical trial registration: NCT03650738