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/m 2 ) 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