NCT06178159

DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer

A Phase II, Multicenter, Open-Label Neoadjuvant Study to Evaluate the Safety and Efficacy of Disitamab Vedotin in Combination With Pertuzumab With or Without Toripalimab for HER2 Positive Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy in patients with HER2-positive breast cancer.

Detailed description

This is an open-label, randomized, multicenter, Phase II Study designed to evaluate safety and efficacy of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy inr patients with HER2-positive breast cancer. The primary objectives of the study are to explore combination neoadjuvant therapy in participants with previously untreated HER2-positive breast cancer, by assessment of pCR .

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Disitamab Vedotin Injection	2.0mg/kg, intravenous infusion，D1, every 2 weeks, Every 6 weeks is a treatment cycle. A total of 3 cycles (18 weeks) of treatment are performed.
DRUG	Pertuzumab Injection	Initial dose 840mg, after 2nd dose 420mg intravenous infusion， every 3 weeks
DRUG	Toripalimab	3.0 mg/kg, intravenous infusion, D1, every 2 weeks

Timeline

• Start date: 2023-11-28
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2023-12-20
• Last updated: 2025-10-01

Locations

1 site across 1 country: China