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

NCT07377643 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2026-02-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Trastuzumab

IV infusion

DRUG

IBI354

IV infusion

DRUG

Docetaxel

IV infusion

DRUG

Pertuzumab

IV infusion

DRUG

Paclitaxel

IV infusion

Sponsors & Collaborators

  • Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-10
Primary Completion
2028-04-28
Completion
2030-05-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07377643 on ClinicalTrials.gov