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.
Have signed the informed consent form (ICF) and are able to comply with the follow-up visits and related procedures required in the protocol.
Male or female participants: ≥18 years of age
Unresectable, locally advanced or metastatic breast cancer, i.e. participants who cannot be treated with curative intent and confirmed HER2-positive (HER2 IHC 3+ or HER2 ISH+) on specimens taken after confirmed locally advanced or metastatic disease by central testing.
Documented history of hormone receptor (HR)-positive (defined as estrogen receptor [ER] and/or progesterone receptor [PgR] positive [ER or PgR ≥1%]) or HR-negative after local testing in the metastatic setting according to ASCO/CAP guidelines. If a participant has more than one ER/PgR result after metastatic disease, the most recent result will be used.
None
Parallel
Trastuzumab
DrugIV infusion
IBI354
DrugIV infusion
Docetaxel
DrugIV infusion
Pertuzumab
DrugIV infusion
Paclitaxel
DrugIV infusion
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment
Defined as time from date of randomisation until the date of objective radiological disease progression according to Blinded Independent Central Review (BICR) using RECIST 1.1 or death by any cause.
Progression Free Survival (PFS) by Investigator assessment
Defined as time from date of randomisation until the date of objective radiological disease progression according to Investigator using RECIST 1.1 or death by any cause.
Overall Survival (OS)
OS is defined as the time from randomisation until the date of death due to any cause.
Objective Response Rate (ORR) by BICR and Investigator assessment
ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR) based on BICR and investigator assessment using RECIST 1.1.
Duration of Response (DoR) by BICR and Investigator Assessment
DoR is defined as the time from date of first detection of objective response until the date of objective radiological disease progression according to BICR and investigator assessment using RECIST 1.1 or death in the absence of progression.
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