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.
This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus Treatment of Physician's Choice (TPC) in subjects with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer who had failed at least one line of systemic chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
376
IV infusion on day 1 and Day 15 of each 28 day cycle
1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
1000-1250 mg/m2, po, bid, from day 1 to Day 15 of each 21 day cycle
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
RECRUITINGProgression-free survival (PFS) assessed by BIRC per RECIST 1.1.
PFS, defined as the time from randomization to PD or death, whichever occurs first.
Time frame: up to 24 months
Overall Survival (OS)
OS, defined as the time from randomization to death
Time frame: up to 24 months
Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1
PFS, defined as the time from randomization to PD or death, whichever occurs first.
Time frame: up to 24 months
Objective Response Rate (ORR)
The percentage of patients with CR and PR assessed by BIRC and investigators per RECIST v 1.1
Time frame: up to 24 months
Disease Control Rate (DCR)
The percentage of patients who have achieved CR,PR and SD assessed by BIRC and investigators per RECIST v 1.1
Time frame: up to 24 months
Duration of Response (DoR)
From the date that response criteria are first met to the first occurrence of PD as determined by BIRC and investigators per RECIST v1.1 or death from any cause, whichever occurs first
Time frame: up to 24 months
Quality of life of patients evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale
To assess the impact of SKB264 on disease related symptoms and health related quality of life (HRQoL) in this patient population
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1000 mg/m2, IV infusion on day 1 and Day 8 of each 21day cycle
25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
Time frame: Up to 2 years
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 observed and recorded from signing the ICF until 30 days after the last dose. AEs occurring 30 days after the last dose are not required to be actively collected by the investigator.