IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer

Sponsor
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Study ID
NCT07377643
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab — DRUG
    IV infusion
  • IBI354 — DRUG
    IV infusion
  • Docetaxel — DRUG
    IV infusion
  • Pertuzumab — DRUG
    IV infusion
  • Paclitaxel — DRUG
    IV infusion

Study Details

This is a randomized, multicenter, open-label, phase 3 study evaluating the efficacy, safety, and tolerability of IBI354 combined with or without pertuzumab vs. THP as first-line treatment for HER2-positive unresectable, locally advanced or metastatic breast cancer.

Key Dates

First listed
Jan 30, 2026
Start date
Feb 10, 2026
Status verified
Feb 2026
Primary completion
Apr 28, 2028
Completion
May 31, 2030

Study Design

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

Arms

  • Experimental: Group A
    IBI354 plus pertuzumab
  • Active Comparator: Group C
    THP
  • Experimental: Group B
    IBI354

Primary Outcome Measure

Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment [ Time Frame: Until progression or death, up to 54 months ]

Central Contacts

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