Efficacy and Safety of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in Advanced Breast Cancer

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study ID
NCT07630103
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Breast Cancer

Eligibility Criteria

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

Interventions

  • Trastuzumab Rezetecan for Injection (SHR-A1811) — DRUG
    SHR-A1811 4.8mg/kg iv q3w
  • Trastuzumab Deruxtecan for Injection (T-DXd) — DRUG
    T-DXd 5.4mg/kg iv q3w

Study Details

This study is a prospective, open-label, multicenter, randomized, parallel Phase II clinical trial. This study aims to investigate the efficacy and safety of trastuzumab rezetecan or trastuzumab deruxtecan in HER2 positive advanced/metastastic breast cancer

Key Dates

First listed
Jun 5, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2031
Completion
Dec 31, 2031

Study Design

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

Arms

  • Experimental: SHR-A1811
  • Active Comparator: T-DXd

Primary Outcome Measure

Progression Free Survival(PFS) [ Time Frame: From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years ]

Central Contacts

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