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