NCT05491694

To Evaluate the Efficacy of Toripalimab Combined With Chemotherapy After HIFU Induction in the Treatment of Early Triple-negative Breast Cancer

To Evaluate the Efficacy and Safety of Toripalimab Combined With Chemotherapy (Epirubicin + Cyclophosphamide → Nab-paclitaxel + Carboplatin) in the Neoadjuvant Treatment of Triple-negative Breast Cancer After High-intensity Focused Ultrasound (HIFU) Induction

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy and safety of terbinumab combined with chemotherapy (epirubicin + cyclophosphamide → nab-paclitaxel + carboplatin) in neoadjuvant therapy of triple-negative breast cancer after HIFU.

Conditions

• Breast Cancer
• TNBC - Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Toripalimab	Toripalimab 240mg
DRUG	Epirubicin	90mg/m2，IVD，q3w
PROCEDURE	High Intensity Focused Ultrasoun	HIFU treatment at lesion site
DRUG	Cyclophosphamide	600mg/m2，IVD，q3w
DRUG	Carboplatin	AUC 5，IVD，q3w
DRUG	Nab-paclitaxel	260mg/m2，IVD，q3w

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-12-30
• Completion: 2024-12-30
• First posted: 2022-08-08
• Last updated: 2022-08-08