NCT07107217

Camrelizumab in Combination With Chemotherapy as Neoadjuvant Treatment in Patients With Early or Locally Advanced Triple-negative Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Blokhin's Russian Cancer Research Center · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To explore the application of Camrelizumab with chemotherapy as neoadjuvant treatment of early-stage TNBC. Phase II clinical study of Camrelizumab in neoadjuvant treatment of early-stage TNBC is proposed. The study aims to evaluate the efficacy and safety of Camrelizumab and to provide a new treatment option for neoadjuvant treatment of early-stage TNBC.

Detailed description

This study is a single center, non blinded, randomized phase II clinical trial. A total of 40 patients early-stage T3-4NanyM0 any TanyN+M0 TNBC, who meet the inclusion and exclusion criteria, are planned to be enrolled. Patients will receive neoadjuvant chemotherapy as 4 course ddAC (doxorubicin 60 mg/m² as an and cyclophosphamide 600 mg/m² on day 1 every 2 weeks) + paclitaxel 80 mg/m² + carboplatin AUC2 on day 1 every 1 weeks a total of 12 weeks with camrelizumab at a dose of 200 mg once every 2 weeks for a total of 16 weeks. Imaging assessments will be conducted every 4 weeks during the neoadjuvant treatment phase. After the neoadjuvant treatment is completed, surgery will be performed within 4 weeks of the last study drug administration. Whether to receive adjuvant treatment after surgery will be determined by the investigator. The primary endpoint of the study is the pathological complete response (pCR) rate. Secondary endpoints include objective response rate (ORR), event-free survival (EFS), overall survival (OS), and safety. During the follow-up phase, survival follow-up will be conducted every 3 months (±28 days) in the first year and every 6 months (±28 days) thereafter, until disease progression, disease recurrence, or until 3 years after the last patient is enrolled (whichever occurs first).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Camrelizumab	200 mg by intravenous (iv.) infusion every 2 weeks (Q2W) for 10 times
DRUG	Doxorubicin +cyclophosphamide+ filgrastimum	Doxorubicin 60mg/m² + cyclophosphamide 600 mg/m² on Day 1 of Cycles 1-4 (Q2W) of the first neoadjuvant phase of the study, IV infusion. filgrastim (G-CSF) subcutaneously on days 2-6 of Cycles 1-4
DRUG	carboplatin + paclitaxel (CP)	carboplatin AUC 2 and paclitacel 80 mg/m² will be given on day 1 every 12 weeks of the second neoadjuvant phase of the study, IV infusion.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2025-08-06
• Last updated: 2025-08-17