This trial was designed to evaluate the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) in subjects with TQB3912 tablets combined with fulvestrant injection and TQB3616 capsules for locally advanced or metastatic HR-positive and HER2-negative breast cancer.And the effectiveness of TQB3912 tablets combined with fulvestrant injection ±TQB3616 capsules in locally advanced or metastatic HR-positive and HER2-negative breast cancer subjects was evaluated by evaluating ORR, PFS, DOR, DCR, CBR, OS, etc., and at the same time, Assess its safety and pharmacokinetic (PK) characteristics.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Protein kinase B(AKT) inhibitors+Cyclin-dependent kinase 4/6(CDK4/6) Inhibitor+Estrogen receptor antagonists.
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Fuzhou First General Hospital
Fuzhou, Fujian, China
Quanzhou First Hospital
Quanzhou, Fujian, China
Meizhou peoples Hospital
Meizhou, Guangdong, China
Guizhou Medical University Affiliated Cancer Hospital Co., Ltd
Guiyang, Guizhou, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Harbin Medical University Cancer
Harbin, Heilongjiang, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Yongzhou Central Hospital
Yongzhou, Hunan, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
...and 7 more locations
Maximum tolerated dose (MTD)
Phase Ib of Queue 2maximum tolerated dose (MTD, if any)
Time frame: 4 months after Queue 2 begins enrollment
phase II recommended dose (RP2D)
Phase II Queue 2: phase II recommended dose (RP2D).
Time frame: 4 months after Queue 2 begins enrollment
Objective Remission Rate (ORR)
Cohort 1, Phase II of Cohort 2: Objective Remission Rate (ORR).
Time frame: 8 to 16 weeks after enrollment
Progression-free survival (PFS)
Refers to the time from the beginning of the first treatment to the first progression of the disease or death for any cause (whichever occurs first).
Time frame: From enrollment to disease progression, an average of 14 months
Duration of response (DOR)
Patient from the date of first documentation of objective remission of the tumor to the date of first documentation of objective progression of the tumor or the date of death due to any cause.
Time frame: From enrollment to disease progression, an average of 14 months
Disease control rate (DCR)
Proportion of participants with complete response, partial response, and stable disease as rated by RECIST v1.1 criteria for best overall efficacy after enrollment of all patients.
Time frame: 8 to 16 weeks after enrollment
Clinical benefit ratio (CBR)
Refers to the percentage of subjects with complete remission (CR), partial remission (PR), or stable disease (SD) determined by the investigator based on RECIST 1.1 for 24 weeks.
Time frame: ≥24 weeks after enrollment
Overall survival (OS)
The time from randomization to death due to any cause.
Time frame: From enrollment to subject death, it is expected to be evaluated until 5 years
Number of patients with adverse events (AEs) and serious adverse events (SAEs)
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: Within 28 days after dosing
Peak time (Tmax)
Refers to the time after a single dose, the blood drug concentration reaches its peak.
Time frame: Within 24 hours after dosing
Peak concentration (Cmax)
Maximum plasma drug concentration.
Time frame: 30 minuets pre-dose at cycle 1 day 1, 8 and day 28. 30 minuets,1, 2, 3, 4, 6, 8, 12, 24 hours after dose at cycle 1 day 1 and day 28. Each cycle is 28 days
Elimination half life (t1/2)
The time it takes for the drug to eliminate half of the body, or the time it takes for the blood drug concentration to be reduced by half.
Time frame: Within 1~7 days after dose
Area under plasma concentration-time curve (AUC0-∞)
The first dosing begins to extrapolate to an infinity plasma concentration-area under the time curve.
Time frame: Within 28 days after dosing
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.