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A Study of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line Treatment for HER2-Positive Recurrent or Metastatic Breast Cancer

NCT07545044 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-22

No results posted yet for this study

Summary

This study is a randomized, controlled, open-label, multicenter, phase II superiority clinical trial. The planned study population consists of participants with HER2-positive recurrent or metastatic breast cancer who have not previously received systemic therapy for advanced disease (participants who have undergone one prior endocrine treatment regimen are eligible for enrollment). The study aims to compare the efficacy and safety of JSKN003 versus trastuzumab combined with pertuzumab and docetaxel as first-line treatment for participants with HER2-positive recurrent or metastatic breast cancer.

Conditions

  • HER2-positive Recurrent or Metastatic Breast Cancer

Interventions

DRUG

JSKN003

6.3 mg/kg, IV, D1, Q3W

DRUG

Trastuzumab

8mg/kg loading dose, then 6mg/kg, IV, D1, Q3W

DRUG

Pertuzumab

840mg loading dose, then 420mg, IV, D1, Q3W

DRUG

Docetaxel

75 mg/m2, IV, D1, Q3W for minimum of 6 cycles or until intolerable toxicity\[ym1.1\]\[z1.2\] or disease progression, whichever occurs first.

Sponsors & Collaborators

  • Shanghai JMT-Bio Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-30
Primary Completion
2027-05-29
Completion
2027-05-30

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Entities

Drugs

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 NCT07545044 on ClinicalTrials.gov