The study will evaluate the safety and efficacy of YL202, when compared with treatment of physician's choice (eribulin, capecitabine, vinorelbine, gemcitabine or sacituzumab govitecan) in participants with unresectable locally advanced, recurrent or metastatic hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer who had failed at least one line of chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
376
IV infusion on day 1 of each 21 day cycle
1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
1000 or 1250 mg/m2, po, bid, from day 1 to Day 14 of each 21 day cycle
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Progression-free survival (PFS) assessed by BIRC per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
PFS is defined as time from randomization until disease progression or death due to any cause.
Time frame: up to 18 months
Overall Survival (OS)
OS is defined as time from randomization until the date of death due to any cause.
Time frame: up to 36 months
Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1
PFS is defined as time from randomization until disease progression or death due to any cause.
Time frame: up to 18 months
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of participants who have a CR or PR, as determined by the BICR/Investigator assessment, per RECIST 1.1.
Time frame: up to 18 months
Duration of Response (DoR)
Duration of response is defined as the time from the date of first documented confirmed response until disease progression, as determined by BICR/Investigator assessment or death due to any cause.
Time frame: up to 18 months
Disease Control Rate (DCR)
DCR is defined as the percentage of participants who have a CR, PR or SD, per RECIST 1.1, as determined by BICR/Investigator assessment, per RECIST 1.1.
Time frame: up to 18 months
Adverse Events (AEs)
Incidence and severity of AEs and clinically significant abnormal laboratory findings.
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1000 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
10 mg/kg, IV infusion on day 1 and Day 8 of each 21 day cycle
Time frame: up to 36 months