Neoadjuvant camrelizumab plus nab-paclitaxel and epirubicin in early triple-negative breast cancer: a single-arm phase II trial

Abstract

Immunotherapy combined with chemotherapy has been demonstrated to be effective in early triple-negative breast cancer (TNBC). In this single-arm, phase II study with Simon's two-stage design, we investigated the efficacy and safety of neoadjuvant camrelizumab plus chemotherapy in patients with early TNBC (NCT04213898). Eligible female patients aged 18 years or older with histologically confirmed treatment-naïve early TNBC were treated with camrelizumab (200 mg, on day 1), nab-paclitaxel (125 mg/m², on days 1, 8, and 15), and epirubicin (75 mg/m², on day 1) every three weeks for six cycles. The primary end point was the pathological complete response; secondary endpoints included safety, objective response rate, and long-term survival outcomes of event-free survival, disease-free survival, and distant disease-free survival. A total of 39 patients were enrolled between January 2020 and October 2021. Twenty-five patients achieved a pathological complete response (64.1%, 95%CI: 47.2, 78.8). The objective response rate was 89.7% (95%CI: 74.8, 96.7), including 35 patients with partial responses. Treatment-related adverse events of grade 3 or 4 occurred in 30 (76.9%) patients. In conclusion, the trial meets the prespecified endpoints showing promising efficacy and manageable safety of neoadjuvant camrelizumab plus nab-paclitaxel and epirubicin chemotherapy in female patients with early TNBC. Long-term survival outcomes are still pending.

Fig. 1. Trial profile.

A total of 97 patients were screened for eligibility, 58 were excluded, and finally 39 were enrolled. All 39 patients received at least one dose of the study treatment and proceeded to surgical resection. All enrolled patients were accessible for efficacy and safety analyses.

Fig. 2. Clinical and pathological response to neoadjuvant camrelizumab plus chemotherapy in 39 patients with early triple-negative breast cancer.

a The waterfall plot showing the best percentage changes in tumor size of target lesions from baseline. Green bars indicate patients having the best overall response of partial response, and yellow bars indicate those having stable disease. The black boxes above indicate patients achieving a pathological complete response (pCR), while gray boxes indicate those without. The gray horizontal line indicates a 30% decrease from the baseline. b The swimmer plot showing the individual patient’s journey from treatment initiation to surgery. The length of the bar indicates the duration from treatment initiation to surgery, and the colors indicate the pathological tumor response (light pink: pCR, baby blue: non-pCR). Tumor response at each assessment is shown as a red circle (partial response), gray cross (stable disease), or purple triangle (progressive disease). The reason for the end of the treatment is shown as a gray triangle (discontinuation due to disease progression), square (discontinuation due to toxicity), or circle (completion). Green lines indicate the duration from the end of the treatment to surgery. Source data are provided as a Source Data file.

Fig. 3. Subgroup analysis of pCR.

Data are presented as percentage and 95% confidential interval (CI). The n indicates the number of patients achieving a pCR; N indicates the total number of patients available for pathological assessment. The black vertical dotted line indicates the pathological complete response rate in the overall population, and the baby blue area shows the corresponding 95% CI. The black squares indicate the pCR for each subgroup of patients, while the length of black horizontal lines indicates the corresponding 95% CI. Source data are provided as a Source Data file.