Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07377643 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Name: IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer — clinical trial record (NCT07377643)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 3

SponsorInnovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

Started2026-02-10

View on ClinicalTrials.gov ↗

Amendment history

2026-02-23

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1

Trial statusNot Yet Recruiting→Recruiting

Start dateestimated 2026-02-28→confirmed 2026-02-10

Study sitesdetails revised at 1 of 1 site

2026-01-22

Original filing

Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

7 trials monitored

See 1 trial at risk

Breast Cancer

5,180 trials monitored

See 256 trials at risk

HER2-Positive Cancer

324 trials monitored

See 21 trials at risk

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.

Trial Details

NCT Number	NCT07377643
Lead Sponsor	Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Conditions	HER2-positive Breast Cancer
Enrollment	540 participants
Start Date	2026-02-10
Primary Completion	2028-04-28 (estimated)
Study Completion	2030-05-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-25