NCT06747338

A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer

A Randomized, Controlled, Open-label, Multicenter, Phase III Clinical Trial to Compare the Efficacy and Safety of KN026 Combined With HB1801 ± Carboplatin Versus Trastuzumab Combined With Pertuzumab and Docetaxel ± Carboplatin in Neoadjuvant Treatment of Early or Locally Advanced HER2-positive Breast Cancer.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: Shanghai JMT-Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized, controlled, open-label, multicenter study will evaluate the safety and efficacy of KN026 in combination with HB1801 ± Carboplatin as neoadjuvant therapy in patients with early or locally advanced HER2-positive breast cancer.

Detailed description

In this randomized, controlled, open-label, multicenter Phase III trial, treatment-naive patients with HER2-positive breast cancer were centrally randomized (1:1) and stratified by disease stage, hormone receptor status, and the planned use of Carboplatin. Participants received six cycles of: neoadjuvant therapy: KN026 combined with HB1801 ± Carboplatin (Experimental) or Trastuzumab plus Pertuzumab and Docetaxel ± Carboplatin (Active Comparator). The primary endpoint was pathological complete response (pCR) in the breast, evaluated in the intention-to-treat (ITT) population.

Conditions

• Early or Locally Advanced HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	KN026	KN026
DRUG	HB1801	HB1801
DRUG	Pertuzumab	Pertuzumab
DRUG	Trastuzumab	Trastuzumab
DRUG	Docetaxel	Docetaxel
DRUG	Carboplatin	Carboplatin

Timeline

• Start date: 2024-12-16
• Primary completion: 2026-12-16
• Completion: 2027-12-16
• First posted: 2024-12-24
• Last updated: 2025-04-24

Locations

1 site across 1 country: China