RecruitingPhase 3NCT06747338

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.


Sponsor

Shanghai JMT-Bio Inc.

Enrollment

520 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase III study is testing a combination of two targeted therapies — KN026 and HB1801 — with or without a chemotherapy drug called carboplatin, given before surgery (called neoadjuvant treatment) in people with HER2-positive breast cancer. HER2-positive means the cancer cells have high levels of a protein that drives tumor growth. **You may be eligible if...** - You are 18 or older - You have been diagnosed with HER2-positive early-stage or locally advanced breast cancer (confirmed by biopsy) - Your cancer is HER2-positive by standard laboratory testing - You have an adequate performance status (able to carry out normal daily activities) - You are willing to undergo surgery after the pre-surgery treatment - You agree to use contraception if applicable **You may NOT be eligible if...** - You have cancer that has spread to distant organs (metastatic disease) - You have poor organ function (kidneys, liver, heart, or bone marrow) - You are pregnant or breastfeeding - You have had prior chemotherapy or targeted therapy for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGKN026

KN026

DRUGHB1801

HB1801

DRUGPertuzumab

Pertuzumab

DRUGTrastuzumab

Trastuzumab

DRUGDocetaxel

Docetaxel

DRUGCarboplatin

Carboplatin


Locations(1)

Clinical Trials Information Group

Shanghai, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06747338