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Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer

NCT06227117 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-03-19

No results posted yet for this study

Summary

The purpose of this study is to evaluate the Safety and Efficacy of Neoadjuvant study of DV in combination Toripalimab i or sequence chemotherapy in HR-negative, HER2 low-expressing Breast Cancer

Conditions

Interventions

DRUG

Disitamab Vedotin Injection （18 weeks）

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

Toripalimab （18weeks）

3.0 mg/kg, intravenous infusion, D1, every 2 weeks

DRUG

Carboplatin

AUC 3 Q2W or AUC1.5 QW intravenous infusion

DRUG

Disitamab Vedotin Injection （12 weeks）

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

Sequential Epirubicin

According to body surface area, 90mg/m2, intravenous infusion, D1, every 3 weeks, A total of 12 weeks of treatment are performed.

DRUG

Sequential CTX

According to body surface area,600mg/m2, intravenous infusion, D1, every 3 weeks, A total of 12 weeks of treatment are performed.

DRUG

Toripalimab （12weeks）

3.0 mg/kg, intravenous infusion, D1, every 2 weeks, A total of 2 cycles (12 weeks) of treatment are performed. Sequential therapy 3.0 mg/kg, intravenous infusion, D1, every 2 weeks, A total of 2 cycles (12 weeks) of treatment are performed.

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Changling Li · 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
2023-07-27
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06227117 on ClinicalTrials.gov