OncRef

Clinical Trial: NCT06747338

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Shanghai JMT-Bio Inc.
Information Provided By:Shanghai JMT-Bio Inc.
Last Update Posted:2026-07-07

Study Overview

Brief 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.

Official Title

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.

Conditions

Early or Locally Advanced HER2-positive Breast Cancer

Intervention / Treatment

  • Drug: KN026
  • Drug: HB1801
  • Drug: Pertuzumab
  • Drug: Trastuzumab
  • Drug: Docetaxel
  • Drug: Carboplatin

Other Study ID Numbers

  • KN026-004

Start Date (Actual)

2024-12-16

Primary Completion Date (Estimated)

2026-12-16

Study Completion Date (Estimated)

2027-12-16

Enrollment (Estimated)

520

Study Type

Interventional

Phase

Phase 3