A Phase II Exploratory Study of Iparomlimab and Tuvonralimab Combined With Chemotherapy in Neoadjuvant Treatment of HR+/HER2- Breast Cancer Patients

Summary

This study is a prospective, multicenter, single-arm, exploratory study. 30 patients with locally advanced HR+/HER2- breast cancer who have not received any treatment were recruited to receive apalutamide voraparib combined with chemotherapy for neoadjuvant therapy. This study adopts Simon's two-stage design: in the first stage, 12 patients need to be enrolled. If among these 12 patients, 1 or fewer patients achieve tpCR, the study will be prematurely terminated due to early failure. Otherwise, 18 patients will be enrolled in the second stage. If 7 or more patients achieve tpCR among the 30 patients, the study achieves the expected results, and the drug can be further studied; otherwise, the study fails, and the drug does not need further study. The aim of this study is to evaluate the efficacy and safety of apalutamide voraparib combined with chemotherapy for neoadjuvant therapy in patients with HR+/HER2- breast cancer.

Timeline

Start

2025-10-10

Primary completion

2027-11-01

Completion

2027-11-01

Drugs

Indications