Multicenter phase 2 trial of neoadjuvant tislelizumab plus nab-paclitacel and carboplatin for triple-negative breast cancer

The phase 2 cTRIO study, at 8 centers in Chine, evaluated neoadjuvant tislelizumab (anti-PD-1) plus nab-paclitaxel and carboplatin (TP) chemotherapy , followed by surgery and adjuvant tislelizumab in patients with early triple-negative breast cancer (TNBC). Patients received six 3-week cycles of neoadjuvant therapy and one year of adjuvant tislelizumab. Among 62 enrolled patients, 44 had PD-L1 positive tumors. Pathologic complete response was observed in 35 patients (pCR rate 56%; 95% CI 43-69). Three year event-free survival and overall survival rates were 82.2% (95 CI 70.2-89.7) and 87.7% (75.6-94.0), respectively. The incidence rates of grade ≥ 3 treatment-related adverse events and grade ≥ 3 immune-related adverse events were 53% and 5%, respectively. The authors conclude that the anthracycline-free neoadjuvant triplet combination showed promising efficacy and safety in patients with early TNBC.