NCT06977542

Neoadjuvant Therapy With Ivonescimab Combined With Chemotherapy for Triple-Negative Breast Cancer

A Single-Arm, Phase II Clinical Study of Neoadjuvant Therapy With Ivonescimab Combined With Chemotherapy in Patients With Early or Locally Advanced Triple-Negative Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, single-arm, investigator-initiated Phase II clinical trial. Eligible patients with treatment-naive early or locally advanced triple-negative breast cancer (TNBC), clinically staged as Stage II-III, will receive neoadjuvant therapy with ivonescimab in combination with chemotherapy prior to surgery. During the neoadjuvant phase, ivonescimab will be administered for a total of 12 doses. Patients who complete the neoadjuvant treatment and are deemed surgically eligible must undergo definitive surgical intervention. Following surgery and pathological evaluation by the local pathology department at each participating center, patients will continue to receive adjuvant therapy with ivonescimab for an additional 14 doses, in addition to any subsequent treatment recommended by the investigator according to standard clinical practice. The primary endpoint of this study is the pathological complete response rate (pCR). Participants will also be followed for secondary endpoints including event-free survival (EFS), disease-free survival (DFS), and distant disease-free survival (DDFS), with a minimum follow-up duration of 2 years post-surgery.

Conditions

• TNBC, Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Ivonescimab	a PD-1/ VEGF Bispecific Antibody, 20mg/kg, every 2 weeks; Chemotherapy : paclitaxel and carboplatin, followed by epirubicin-cyclophosphamide

Timeline

• Start date: 2025-06-01
• Primary completion: 2029-01-01
• Completion: 2032-01-01
• First posted: 2025-05-18
• Last updated: 2025-05-18