A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT07497386
Phase
PHASE2
Status
Recruiting
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Conditions

  • Unresectable Locally Metastatic Breast Cancer
  • Unresectable Locally Recurrent Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab Rezetecan for Injection — DRUG
    Trastuzumab Rezetecan for injection.
  • Trastuzumab Deruxtecan for Injection — DRUG
    Trastuzumab Deruxtecan for injection.

Study Details

The study is designed to compare the efficacy and safety of different dose groups of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in patients with HR-positive, HER2-low unresectable locally recurrent/metastatic breast cancer. It will also exploratively evaluate the pharmacokinetic profile and immunogenicity of Trastuzumab Rezetecan.

Key Dates

Start date
Apr 28, 2026
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Trastuzumab Rezetecan for Injection
    Trastuzumab Rezetecan for Injection, different doses.
  • Experimental: Trastuzumab Deruxtecan for Injection

Primary Outcome Measure

Progression-free survival (PFS). [ Time Frame: Every 6 weeks after administration, approximately 14 months. ]

Central Contacts