NCT05426486

A Study of ARX788 Combined With Pyrotinib Maleate Versus TCBHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

A Randomized, Open Label, Multi-center Phase II-III Neoadjuvant Study Comparing the Efficacy and Safety of ARX788 Combined With Pyrotinib Maleate Versus TCBHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) in Patients With HER2-positive Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Caigang Liu · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open label Phase II-III neoadjuvant study comparing the efficacy and safety of ARX788 combined with pyrotinib maleate versus TCBHP (trastuzumab plus pertuzumab with docetaxel and carboplatin) in patients with HER2-positive breast cancer.

Detailed description

This is a randomized, open label Phase II-III neoadjuvant study comparing the efficacy and safety of ARX788 combined with pyrotinib maleate versus TCBHP (trastuzumab plus pertuzumab with docetaxel and carboplatin) in patients with HER2-positive breast cancer. Patients will be randomized (1:1) to one of the two treatment arms: arm 1, ARX788 plus pyrotinib maleate for 6 cycles; arm 2, trastuzumab plus pertuzumab with docetaxel and carboplatin for six cycles. Patients will undergo surgery after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	ARX788	HER2 antibody-drug conjugate
DRUG	Pyrotinib maleate	EGFR/HER2 dual inhibitor
DRUG	Trastuzumab	anti-Her2 monoclonal antibody
DRUG	Pertuzumab	anti-HER2 monoclonal antibody
DRUG	Docetaxel	Cytotoxic chemotherapy
DRUG	Carboplatin	Cytotoxic chemotherapy

Timeline

• Start date: 2022-05-23
• Primary completion: 2025-12-30
• Completion: 2028-12-30
• First posted: 2022-06-22
• Last updated: 2024-10-30

Locations

1 site across 1 country: China