The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer who have previously failed endocrine therapy.
This is a randomized, open-label, multicenter phase 3 clinical study to evaluate the efficacy and safety of SKB264 monotherapy versus investigator's choice of chemotherapy (ICC) in subjects with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer who had failed at least one line of systemic chemotherapy and have not recieved systemic chemotherapy for locally advanced, relapsed, or metastatic stages.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
430
5mg/kg, IV on Day 1 and Day 15 of each 28 day cycle
100 mg/m\^2, IV, on Days 1, 8, and 15 every 4 weeks
90 mg/m\^2, IV, on Days 1, 8, and 15 every 4 weeks; or 80 mg/m\^2, IV, weekly, every 3 weeks
1000-1250 mg/m\^2, orally, Days 1-14, twice daily, every 3 weeks
The Fifth Medical Center of the Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGProgression 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 24 months
Overall 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 67 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 24 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 24 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 24 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 24 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 24 months
AEs and SAEs
Incidence and severity of AEs and SAEs (per CTCAE 5.0), and clinically significant abnormal laboratory findings
Time frame: AEs should be collected from signing the informed consent form (ICF) until 30 days after the last dose
Mean change from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
To assess the impact of SKB264 on disease related symptoms and health related quality of life (HRQoL) in this patient population
Time frame: Randomization up to approximately 24 months
Mean change from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module 23 (EORTC QLQ-BR23)
To assess the impact of SKB264 on disease related symptoms and health related quality of life (HRQoL) in this patient population
Time frame: Randomization up to approximately 24 months
Anti-drug Antibodies (ADA) for SKB264
Immunogenicity test results and titer values of SKB264
Time frame: Day1 and Day15 of Cycle 1 (each cycle is 28 days), Day1 of Cycle 3, Cycle 6, and so on (every 3 cycles), up to approximately 24 months
Maximum observed plasma concentration (Cmax) of SKB264-ADC, SKB264-TAB and free KL610023
To assess the pharmacokinetic (PK) profile of SKB264.
Time frame: Day1 and Day15 of Cycle 1 (each cycle is 28 days), Day1 of Cycle 3, Cycle 6, and so on (every 3 cycles), up to approximately 24 months
Minimum observed plasma concentration (Cmin) of SKB264-ADC, SKB264-TAB and free KL610023
To assess the pharmacokinetic (PK) profile of SKB264.
Time frame: Day1 and Day15 of Cycle 1 (each cycle is 28 days), Day1 of Cycle 3, Cycle 6, and so on (every 3 cycles), up to approximately 24 months
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