RecruitingPhase 3NCT07377643

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

A Randomized, Multicenter, Open-label Phase 3 Study to Compare IBI354 With or Without Pertuzumab vs. Taxane in Combination With Trastuzumab and Pertuzumab as First-line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Breast Cancer


Sponsor

Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

Enrollment

540 participants

Start Date

Feb 10, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares IBI354 (an antibody-drug conjugate — a targeted cancer drug with an attached chemotherapy payload) with or without pertuzumab versus a standard regimen of taxane chemotherapy plus trastuzumab and pertuzumab as a first-line treatment for HER2-positive metastatic breast cancer. **You may be eligible if...** - You are 18 or older with confirmed HER2-positive metastatic or locally advanced breast cancer that cannot be surgically removed - You have not received prior chemotherapy or HER2-targeted therapy for advanced or metastatic disease - Your overall health status is good (ECOG 0–1) - Your heart function, blood counts, liver, and kidneys are within acceptable ranges - You have at least one measurable tumor lesion **You may NOT be eligible if...** - You have previously received antibody-drug conjugates containing topoisomerase I inhibitors - You have uncontrolled heart disease, a recent heart attack, or a significant heart rhythm problem - You have a history of serious lung inflammation (interstitial lung disease) - You are pregnant or breastfeeding - You have active or uncontrolled infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrastuzumab

IV infusion

DRUGIBI354

IV infusion

DRUGDocetaxel

IV infusion

DRUGPertuzumab

IV infusion

DRUGPaclitaxel

IV infusion


Locations(1)

Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

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NCT07377643


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