NCT06389006

To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer

A Single-arm, Open-label, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (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 combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer

Detailed description

This is a single-arm, open-label, multicenter phase II clinical trial to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as neoadjuvant treatment in patients with HR-positive, HER2-low breast cancer

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Disitamab Vedotin for Injection	2.0mg/kg, intravenous infusion，D1, every 2 weeks, Every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed
DRUG	Toripalimab	3.0 mg/kg, intravenous infusion, D1, every 2 weeks, every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed. Sequential therapy 3.0 mg/kg, intravenous infusion, D1, every 2 weeks,every 6 weeks is a treatment cycle. A total of 2 cycles (12 weeks) of treatment are performed.
DRUG	Epirubicin	According to body surface area, 90mg/m2, intravenous infusion, D1, every 3 weeks, Every 6 weeks is a treatment cycle. A total of 12 weeks of treatment are performed.
DRUG	Cyclophosphamide	According to body surface area,600mg/m2, intravenous infusion, D1, every 3 weeks , Every 6 weeks is a treatment cycle. A total of 12 weeks of treatment are performed

Timeline

• Start date: 2024-04-29
• Primary completion: 2025-06-01
• Completion: 2026-12-31
• First posted: 2024-04-29
• Last updated: 2024-05-23

Locations

1 site across 1 country: China