The aim of the study is to evaluate the efficacy and safety of SKB264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC) whose tumors do not express programmed cell death ligand 1 (PD-L1) or in patients with PD-L1 positive tumors who received prior anti-programmed cell death 1 (PD-1)/PD-L1 inhibitor in early setting
This is a randomized, open-label, multicenter, Phase 3 study to evaluate the efficacy and safety of SKB264 versus investigator's choice chemotherapy as first-line treatment for patients with unresectable recurrent or metastatic TNBC whose tumors do not express PD-L1 or in patients with PD-L1 positive tumors who received prior anti-PD-1/PD-L1 inhibitor in early setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
524
IV Infusion
IV Infusion.
IV infusion.
Tablet. Oral route of administration.
IV infusion.
IV infusion.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGOverall Survival (OS)
OS is defined as the time from randomization until the date of death due to any cause.
Time frame: Randomization up to approximately 40 months
Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.
Time frame: Randomization up to approximately 28 months
Objective Response Rate (ORR)
ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by BICR/investigator per RECIST 1.1
Time frame: Randomization up to approximately 28 months
Duration of Response (DoR)
DoR is defined as the time from the date of first documented CR or PR until date of documented disease progression per RECIST 1.1, as assessed by BICR/investigator or death due to any cause, whichever occurs first.
Time frame: Randomization up to approximately 28 months
Progression-Free Survival (PFS) assessed by Investigator
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator or death due to any cause, whichever occurs first.
Time frame: Randomization up to approximately 28 months
Disease control rate (DCR)
DCR is defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by BICR/investigator per RECIST 1.1
Time frame: Randomization up to approximately 28 months
Time to Response (TTR)
TTR is defined as the time from the date of randomization until the first documentation of CR or PR as assessed by BICR/investigator per RECIST 1.1.
Time frame: Randomization up to approximately 28 months
Adverse events(AEs) and severe adverse events (SAEs)
Incidence and severity of AEs and SAEs, and clinically significant lab abnormalities
Time frame: AEs should be collected from signing the informed consent form (ICF) until 30 days after the last dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.