Efficacy, safety, and biomarker analysis of neoadjuvant camrelizumab plus apatinib as a chemotherapy-free strategy for early-stage triple-negative breast cancer: a phase II study.

BACKGROUND: Neoadjuvant chemotherapy, a cornerstone of early-stage triple-negative breast cancer (TNBC) treatment, has limited efficacy and is often accompanied by substantial toxicity. As a promising chemotherapy-free alternative, the combination of immune checkpoint inhibitors and anti-angiogenic agents provides the potential to enhance antitumor efficacy by remodeling the tumor microenvironment while reducing treatment-related adverse events (TRAEs). This study aimed to assess the clinical value and feasibility of neoadjuvant camrelizumab plus apatinib in patients with early-stage TNBC. METHODS: This study enrolled stage II-III TNBC patients with baseline tumor-infiltrating lymphocytes (TILs) > 10%. Participants received 8 cycles of neoadjuvant treatment, consisting of intravenous camrelizumab 200 mg every 21 days (or 3 mg/kg for patients weighing < 50 kg), combined with oral apatinib 250 mg daily. The primary endpoint was pathological complete response (pCR) rate; secondary endpoints included objective response rate (ORR), disease-free survival (DFS), overall survival, and safety. RESULTS: Between December 2022 and March 2024, 25 patients were screened, 14 were recruited and treated, 13 were evaluable for efficacy, and 11 subsequently underwent surgery. The results showed a pCR rate of 27.3% (3/11), an ORR of 46.2% (6/13), and a 24-month DFS rate of 90.9%. TRAEs were predominantly of grade 1-2, with grade ≥ 3 events occurring in 28.6% patients. Exploratory transcriptomic analysis identified differences in genes related to extracellular matrix remodeling and immune regulation. CONCLUSIONS: Camrelizumab plus apatinib demonstrated manageable toxicity and preliminary antitumor activity, supporting further investigation of this chemotherapy-free strategy in early-stage TNBC patients with enriched TILs. TRIAL REGISTRATION: NCT05556200 (Registration Date: September 27, 2022).