RT Journal Article
SR Electronic
T1 Phase II Study of Nab-paclitaxel Plus Cyclophosphamide Plus Trastuzumab Neoadjuvant Chemotherapy in Early HER-2-positive Breast Cancer
JF Anticancer Research
JO Anticancer Res
FD International Institute of Anticancer Research
SP 3899
OP 3904
DO 10.21873/anticanres.15185
VO 41
IS 8
A1 MISATO OGINO
A1 TAKAAKI FUJII
A1 YUKIO KOIBUCHI
A1 YUKO NAKAZAWA
A1 DAISUKE TAKATA
A1 KEN SHIRABE
YR 2021
UL http://ar.iiarjournals.org/content/41/8/3899.abstract
AB Background/Aim: This phase II trial evaluated the efficacy and safety of neoadjuvant nab-paclitaxel plus cyclophosphamide (CPA) plus trastuzumab (AbraC-HER) in patients with early HER2-positive breast cancer. Patients and Methods: This was a single-arm, open-label, single-center prospective phase II study. The primary endpoint was pathological complete response rate (pCR rate). The secondary endpoints were clinical antitumor efficacy and the frequency and severity of adverse events. Results: Fifty-nine patients were enrolled in this study. pCR (ypT0/is ypN0) was achieved in 29 patients (49%). The overall response rate was 88.1% (52/59) in all patients. Dose reductions because of adverse events occurred in 3 patients (5.1%) and relative dose intensity was 98%. Compared to Abra-HER, AbraC-HER induced fewer adverse effects. Conclusion: Treatment with nab-paclitaxel plus CPA plus trastuzumab was tolerable and effective with a high pCR rate. This AbraC-HER neoadjuvant therapy may be a feasible new treatment option for patients with early HER2-positive breast cancer.