This is a phase III clinical trial to evaluate the efficacy and safety of XZP-3287 in combination with Fulvestrant versus placebo combined with Fulvestrant in Patients who have HR positive and Her2 negative recurrent/metastatic breast cancer and have received prior endocrine therapy are eligible for study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
XZP-3287 360 mg orally Twice daily(Q12H) of every 28-day cycle Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle (28-day) until progressive disease
Placebo 360 mg orally Twice daily(Q12H) of every 28-day cycle Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle (28-day) until progressive disease
Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Investigator-assessed progression free survival (PFS)
An interim analysis will be performed in this study. The primary endpoint of the study is PFS. An interim analysis is scheduled upon the collection of 70%(approximately 125) PFS events, and the final PFS analysis will be conducted after 178 PFS events have been collected.
Time frame: Up to approximately 24 months
BICR-assessed progression free survival (PFS)
Time frame: Up to approximately 24 months
Overall survival (OS)
Time frame: Up to approximately 5 years
Overall survival rate(OSR)
Time frame: Up to approximately 5 years
Objective response rate (ORR)
Time frame: Up to approximately 24 months
Duration of response (DoR)
Time frame: Up to approximately 24 months
Disease control rate (DCR)
Time frame: Up to approximately 24 months
Clinical benefit rate (CBR)
Time frame: Up to approximately 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to approximately 24 months
Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0
Time frame: Up to approximately 24 months
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Maximum Plasma Concentration [Cmax]
Time frame: Up to approximately 4 months
Time to Maximum Plasma Concentration [Tmax]
Time frame: Up to approximately 4 months
Area under the time-concentration Curve [AUC]
Time frame: Up to approximately 4 months