This is a phase III clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Fulvestrant versus placebo combined with Fulvesrant 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
357
SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Placebo 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle until progressive disease
Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Investigator-assessed PFS
Investigator-assessed Progression Free Survival
Time frame: Up to approximately 24 months.
Progression-free Survival (PFS) per RECIST 1.1
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.
Time frame: Up to approximately 24 months.
OS
Overall Survival
Time frame: Up to approximately 2 years
ORR
Objective Response Rate
Time frame: Up to approximately 24 months.
DoR
Duration of Objective Response
Time frame: Up to approximately 24 months
CBR
Clinical Benefit rate
Time frame: Up to approximately 24 months.
AEs and SAEs
Number of Participants With adverse events (AEs) and serious adverse events (SAEs) Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.
Time frame: Up to approximately 24 months.
Ctrough
Ctrough
Time frame: Up to 4 weeks
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