SBRT, Chemotherapy, and AK112 Neoadjuvant Therapy for Triple-negative Breast Cancer (TNBC) - Trial NCT06401005

Timeline & Enrollment

Primary Outcome

Complete pathologic remission (pCR) rate

Summary

Studies have indicated that the improvement in pathological complete response (pCR) is
 significantly correlated with triple-negative breast cancer（TNBC）patients' overall survival
 (OS). Patients with TNBC have poor efficacy for neoadjuvant chemotherapy. The combination of
 neoadjuvant therapy with immunotherapy and chemotherapy has been demonstrated to enhance the
 pCR rate of TNBC patients, increasing it from 45% to approximately 60%. Therefore, how to
 further improve the pCR rate of luminal-type breast cancer became the main objective of this
 study. Stereotactic radiotherapy (SBRT) not only kills tumor cells directly, but also kills
 the distant unirradiated tumor cells by promoting the cross-initiation of tumor-specific CD8+
 T cells, a phenomenon known as the abscopal effect. Our research team has recently discovered
 that the triple therapy model of SBRT + anti-vascular targeting + anti-PD-1 was safe and
 efficacious in lung cancer patients. Ivonescimab (AK112) is an anti-PD-1/VEGF-A bispecific
 antibody. In order to improve the pCR, a single-arm, open, phase II clinical study was
 proposed to explore the safety and efficacy of SBRT+AK112+chemotherapy, a neoadjuvant
 treatment modality, in the treatment of TNBC.

ICD-10 Classifications