A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer

Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study ID
NCT07679360
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Trastuzumab Rezetecan for Injection — DRUG
    Trastuzumab Rezetecan for Injection.
  • Adebrelimab Injection — DRUG
    Adebrelimab Injection.
  • Capecitabine tablets — DRUG
    Capecitabine Tables.
  • Pembrolizumab injection — DRUG
    Pembrolizumab Injection.

Study Details

It is a randomized, open label, positive drug controlled, multicenter design Phase III clinical trial, aims to compare the efficacy and safety of SHR-A1811 combined with Adebrelimab and the treatment selected by the researchers in the adjuvant treatment of triple negative breast cancer with invasive residual cancer after neoadjuvant treatment, and to explore the PK characteristics and immunogenicity of SHR-A1811 and Adebrelimab.

Key Dates

First listed
Jul 1, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2032

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Trastuzumab Rezetecan combined with Adebrelimab Group
    Trastuzumab Rezetecan combined with Adebrelimab.
  • Active Comparator: Capecitabine and Pembrolizumab
    Capecitabine or Pembrolizumab or Capecitabine combined with Pembrolizumab.

Primary Outcome Measure

Invasive disease-free survival (iDFS) [ Time Frame: Until study completion, assessed up to approximately 5 years. ]

Central Contacts

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