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A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer

NCT07441460 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2026-04-08

No results posted yet for this study

Summary

This is a randomized, controlled, open-label, multicenter, Phase Ⅲ clinical study designed to compare the efficacy and safety of KN026 combined with HB1801 and chemotherapy versus trastuzumab combined with pertuzumab and chemotherapy as adjuvant therapy in participants with HER2-positive breast cancer.

Conditions

  • Resectable HER2-positive Breast Cancer

Interventions

DRUG

KN026

In accordance with the protocol

DRUG

HB1801

In accordance with the protocol

DRUG

Trastuzumab

Intravenous infusion

DRUG

Pertuzumab

Intravenous infusion

DRUG

Docetaxel

Intravenous infusion

DRUG

Epirubicin

Intravenous infusion

DRUG

Doxorubicin

Intravenous infusion

DRUG

Cyclophosphamide

Intravenous infusion

DRUG

Carboplatin

Intravenous infusion

Sponsors & Collaborators

  • Shanghai JMT-Bio Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-06
Primary Completion
2034-08-07
Completion
2035-08-07

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07441460 on ClinicalTrials.gov