Anthracycline-Free Neoadjuvant Therapy With Nab-Paclitaxel and Carboplatin in Non-Luminal Breast Cancer: A Single-Arm Clinical Trial.

Abstract

Anthracycline-free regimens have attracted growing interest because of less cardiac toxicity, especially in HER2-positive breast cancer when used in combination with trastuzumab and pertuzumab. This prospective, single-center trial (NEOPATH) aimed to assess the efficacy and safety of nab-paclitaxel combined with carboplatin in the neoadjuvant therapy of non-luminal breast cancer. The study was conducted in Ruijin Hospital between April 2019 and October 2021. Patients who had stage II-III TNBC or HER2-positive breast cancer were enrolled. Participants were treated with neoadjuvant nab-paclitaxel (100 mg/m2) and carboplatin (area under the curve 2) on days 1, 8, and 15, for four 4-week cycles. Concurrent trastuzumab at 2 mg/kg (loading dose 4 mg/kg) and pertuzumab 420 mg (loading dose 840 mg) were given in patients with HER2-positive tumors. The primary endpoint was pathological complete response (pCR) rate. Secondary endpoints included pCR rate in predefined subgroups, objective response rate (ORR), event-free survival (EFS), and safety profile. A total of 106 patients were enrolled in the study and 99 of them proceeded to surgery. The pCR (ypT0/is N0) rate was 41.41% in total, 33.78% in TNBC and 64.00% in HER2-positive breast cancer. Three-year EFS were 87.24% and 91.43% in TNBC and HER2-positive groups. ORR was 72.49% in total, 67.12% in TNBC and 88.00% in HER2-positive breast cancer. The most frequent grade 3 or higher adverse events were neutropenia (57%), vomiting (11%), and thrombocytopenia (8%). In conclusion, this anthracycline-free neoadjuvant regimen of nab-paclitaxel combined with carboplatin in non-luminal breast cancer demonstrated promising efficacy and was well-tolerated. Trial Registration: ClinicalTrials.gov under identifier NCT03907800.