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.

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. 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. 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. 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. NCT05556200 (Registration Date: September 27, 2022).