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
The study consists of two stages Stage I is an open-label, multicenter, randomized, parallel-controlled phase II clinical study, and its primary objective is 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 based on ORR and PFS results. Stage II is an open-label, multicenter, randomized, parallel-controlled phase III clinical study, and its primary objective is 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 based on PFS results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
706
HLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan. HLX22 is a novel monoclonal antibody targeting HER2 .
HLX87 is a novel HER2-targeted ADC with a similar mechanism of action to trastuzumab deruxtecan
T-Dxd is a HER2-targeted ADC
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGObjective response rate (ORR) (assessed by the blinded independent central review [BICR] as per RECIST v1.1)
Time frame: up to 26 months
Progression-free survival (PFS) (assessed by BICR as per RECIST v1.1)
Time frame: up to 37 months
● ORR (assessed by the investigator as per RECIST v1.1)
Time frame: up to 26 months
● PFS (assessed by the investigator as per RECIST v1.1)
Time frame: up to 37 months
Second progression-free survival (PFS2)
Time frame: up to 37 months
Overall survival (OS)
Time frame: up to 37 months
Incidence and severity of adverse events (AEs)
severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version 6.0
Time frame: up to 37 months
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Pertuzumab+ Trastuzumab+Docetaxel