DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer
NCT06178159 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-10-01
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.
Conditions
Interventions
- 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
Sponsors & Collaborators
-
RemeGen Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jianmin Fang, Ph.D · RemeGen Co., Ltd.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-28
- Primary Completion
- 2026-06-30
- Completion
- 2026-12-31
Countries
- China
Study Locations
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