NCT07197697

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Anhui Provincial Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab Injection (QL1706) combined chemotherapy	The dosage of Iparomlimab and Tuvonralimab Injection is 5mg/kg, administered intravenously, with each treatment cycle lasting every 3 weeks. The chemotherapy regimen is AC-T: epirubicin 100mg/m2, cyclophosphamide 600mg/m2, every 3 weeks for 4 cycles; followed by paclitaxel 80mg/m2, every week for 12 cycles. A total of 8 cycles of neoadjuvant chemotherapy combined with immunotherapy were performed before the surgery. It is recommended that the surgery be conducted within 4 weeks after the completion of neoadjuvant treatment. The postoperative adjuvant treatment can be continued with postoperative adjuvant chemotherapy and the treatment of the etolo combination antibody according to the decision of the researcher and/or the willingness of the subject.

Timeline

• Start date: 2025-10-10
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2025-09-29
• Last updated: 2025-09-29