NCT06968585

A Study of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy

A Phase III,Multicenter,Randomized,Open-Label,Active-Controlled Trial of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 365 (actual)
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the efficacy of A166 versus trastuzumab emtansine (T-DM1) in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxane therapy

Detailed description

This study will evaluate the efficacy of A166 versus trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxane therapy To further evaluate the efficacy of A166 versus T-DM1 in patients with HER2-positive unresectable or metastatic breast cancer, based on effectiveness endpoints including: Overall survival (OS) Progression-free survival (PFS) as assessed by investigators Objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and clinical benefit rate (CBR) assessed by both blinded independent central review (BICR) and investigators. To assess the safety profile of A166 for injection in patients with HER2-positive unresectable or metastatic breast cancer. To evaluate the immunogenicity of A166 for injection in patients with HER2-positive unresectable or metastatic breast cancer. To characterize the pharmacokinetic (PK) profile of A166 for injection in patients with HER2-positive unresectable or metastatic breast cancer.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	A166	intravenous(IV) infusion (Q3W)
DRUG	T-DM1	intravenous(IV) infusion (Q3W)

Timeline

• Start date: 2023-07-18
• Primary completion: 2025-11-30
• Completion: 2028-03-31
• First posted: 2025-05-13
• Last updated: 2025-05-13

Locations

1 site across 1 country: China