NCT06313086

DP303c Versus Trastuzumab Emtansine in in Patients With HER2-positive Advanced Breast Cancer

A Multicentre, Randomized, Open-label, Controlled Phase Ш Clinical Study to Evaluate the Efficacy and Safety of DP303c Versus Trastuzumab Emtansine in Patients With HER2-positive Advanced Breast Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 442 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Clinical Study to Evaluate the Efficacy and Safety of DP303c versus trastuzumab emtansine in patients with HER2-positive Advanced Breast Cancer

Detailed description

This is a multi-centre, randomized, open-label, controlled phase Ш clinical study to evaluate the efficacy and safety of DP303c injection versus trastuzumab emtansine in in patients with HER2-positive advanced breast cancer. Patients will be treated with DP303c injection at 3.0 mg/kg or trastuzumab emtansine at 3.6 mg/kg every 3 weeks. Patients will continue to receive treatment until disease progression, intolerable toxicity, withdrawal of informed consent, death, or any other reasons for treatment discontinuation, whichever occurs first.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	DP303c	intravenous injection
DRUG	trastuzumab emtansine	intravenous injection

Timeline

• Start date: 2024-03-13
• Primary completion: 2025-12-01
• Completion: 2028-02-01
• First posted: 2024-03-15
• Last updated: 2024-05-10

Locations

1 site across 1 country: China