NCT05901935

DP303c 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 DP303cversus Trastuzumab Combined With Vinorelbine/Capecitabine in of HER2-positive Advanced Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study of DP303c 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 combined with vinorelbine/capecitabine in the treatment of HER2-positive advanced breast cancer. Patients will be treated with DP303c injection at 3.0 mg/kg or trastuzumab combined with vinorelbine/capecitabine 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 Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	DP303c	DP303c injection, 3.0 mg/kg, Q3W.
DRUG	Trastuzumab	IV, 6 mg/kg, D1, Q3W
DRUG	Vinorelbine Tartrate	IV, 25 mg/m\^2，D1、D8，Q3W
DRUG	Capecitabine tablets	PO 1000 mg/m\^2, bid, D1-D14, Q3W

Timeline

• Start date: 2023-07-01
• Primary completion: 2026-01-01
• Completion: 2028-07-01
• First posted: 2023-06-13
• Last updated: 2023-06-13