The aim of this study was to evaluate whether the progression-free survival of SHR-A1811 was superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer. To evaluate whether SHR-A1811 is superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
530
SHR-A1811 is a lyophilized powder for injection intravenously. Administered according to label, as one option for Physician's Choice.
Administered according to label, as one option for Physician's Choice (determined before randomization).
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGProgression-free Survival (PFS) Based on Blind Independent Video Review Committee (BIRC)
Time frame: within approximately 2 years
Overall Survival (OS)
Time from the date of randomization to the date of death for any cause. If there is no death reported for a participant before the data cutoff for OS analysis, OS will be censored at the last contact date at which the participant is known to be alive.
Time frame: within approximately 3 years
Objective Response Rate (ORR)
Percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR), confirmed by a second assessment.
Time frame: within approximately 2 years
Duration of Response (DoR)
DoR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.
Time frame: within approximately 2 years
Clinical Benefit Rate (CBR)
CBR is defined as complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1.
Time frame: within approximately 2 years
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