A Trial Comparing GQ1005 and T-DM1 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer

Sponsor
GeneQuantum Healthcare (Suzhou) Co., Ltd.
Study ID
NCT07673029
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • GQ1005 — DRUG
    Administered I.V.
  • T-DM1 — DRUG
    Administered I.V.

Study Details

This study is designed to compare efficacy and safety of GQ1005 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane.

Key Dates

First listed
Jun 29, 2026
Start date
Jan 10, 2025
Status verified
Jun 2026
Primary completion
Jan 9, 2027
Completion
Jan 9, 2028

Study Design

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

Arms

  • Experimental: GQ1005
    GQ1005 will be administered intravenously every 21 days.
  • Experimental: T-DM1
    T-DM1 will be administered intravenously every 21 days.

Primary Outcome Measure

Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) [ Time Frame: Up to approximately 24 months ]

Central Contacts

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