This is a open-label, multicenter phase Ib study to evaluate safety and efficacy of TQ-B3525 tablets combined with fulvestrant injection in subjects with HR-positive, HER2-negative and PIK3CA mutation advanced breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
TQ-B3525 tablets were taken orally, once daily in 28-day cycle; The doses were 20 mg and 30 mg.
Fulvestrant injection 500mg administered intravenously (IV) on day 1, day 15 of first cycle and on day 1 of follow-up treatment cycle. Each cycle is 28 days.
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Hospital of Jilin university
Changchun, Jilin, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Dose-limiting toxicity (DLT)
Subjects appear the toxic reaction relate to the drug after treatment within 28 days.
Time frame: up to 28 days
Overall response rate (ORR) assessed by investigator
Percentage of participants achieving complete response (CR) and partial response (PR).
Time frame: up to 72 weeks
Disease control rate(DCR)
Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
Time frame: up to 72 weeks
Duration of Response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Time frame: up to 72 weeks
Progression-free survival (PFS)
PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Time frame: up to 72 weeks
Overall survival (OS)
OS defined as the time from the first dose to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Time frame: up to 72 weeks
Cmax
Cmax is the maximum plasma concentration of TQ-B3525 or metabolite(s).
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours post-dose on day 1; Hour 0 of day 15; and hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours post-dose on day 28.
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Tmax
To characterize the pharmacokinetics of TQ-B3525 by assessment of time to reach maximum plasma concentration.
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours post-dose on day 1; Hour 0 of day 15; and hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours post-dose on day 28.
AUC0-t
To characterize the pharmacokinetics of TQ-B3525 by assessment of time to reach maximum plasma concentration.
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours post-dose on day 1; Hour 0 of day 15; and hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24 hours post-dose on day 28.