About this trial
The study is being conducted to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer
Eligibility criteria
Qualifiers
Advanced or metastatic breast cancer.
HER2-positive as determined by the central laboratory, defined as IHC 3+, or IHC 2+ and ISH+.
Positive or negative for hormone receptor HR (including estrogen receptor [ER] and progesterone receptor [PgR]) as determined by the central laboratory 4. No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer (1 line of endocrine therapy is allowed).
Disqualifiers
1. History of a second malignancy within 3 years prior to signing the ICF. 2. Previous use of doxorubicin with a concentration of > 360 mg/m2 (or equivalent).
Trial design
Treatments tested in this trial
- HLX87 + HLX22
- HLX87 + Pertuzumab
- T-Dxd + Pertuzumab
- THP