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

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 ID

NCT07377643

Phase

PHASE3

Sponsor

Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

Status

RECRUITING

Cancer Type

Breast Cancer

Interventions

Trastuzumab
IBI354
Docetaxel
Pertuzumab
Paclitaxel

Locations (sample)

Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

Note: CNS lesions will not be considered target lesions.
Non-remission of adverse events (AEs) after previous anti-cancer treatment, defined as AEs that have not been relieved to ≤ grade 1 or baseline bef…
Tumor invades surrounding important tissues and organs (such as mediastinal great vessels, superior vena cava and inferior vena cava, pericardium, …
Bleeding within 3 months prior to the first dose of study treatment that is life-threatening and requires blood transfusion or invasive treatment.

For full eligibility, visit ClinicalTrials.gov.

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