Multicenter phase 3 trial of neoadjuvant nab-paclitaxel versus docetaxel-carboplatin, both with trastuzumab and pertuzumab, for HER2-positive early breast cancer

The phase 3 HELEN-006 trial, at six centers in China, compared neoadjuvant nab-paclitaxel with trastuzumab and pertuzumab (nab-paclitaxel group) versus neoadjuvant standard docetaxel-carboplatin-trastuzumab-pertuzumab (docetaxel-carboplatin group) in patients with HER2-postive early-stage breast cancer. The primary endpoint was pathological complete response (pCR; ypT0/is ypN0). pCR was seen in 66.3% in the nab-paclitaxel group versus 57.6% in the docetaxel-carboplatin group (OR 1.54; p=0.011). Grade 3 or 4 adverse events were seen in 30% of the patients in the nab-paclitaxel group and 38% of the patients in the docetaxel-carboplin group. There were no grade 5 adverse events in either group. The authors conclude that these findings suggest an potential advantage of nab-paclitaxel combined with trastuzumab and pertuzumab compared with the standard regimen in neoadjuvant therapy for patients with HER2-positive early breast cancer.