The study is being conducted to evaluate the efficacy, safety and tolerability of pyrotinib combination with CDK4/6 Inhibitor SHR6390 in advanced HER2-Positive breast cancer patients who prior trastuzumab-treated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Breast Cancer Center, Shandong Cancer Hospital Affiliated to Shandong University
Jinan, China
RECRUITINGObjective Overall Response Rate (ORR)
ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable. The ORR will be reported by percentage with each arms and appropriate confidence intervals.
Time frame: 2 months
Progression-Free Survival (PFS)
PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first.
Time frame: Up to 3 years
Overall Survival (OS)
Overall Survival (OS), defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study medication and participants with no post-baseline information were censored at the date of randomization.
Time frame: Up to 3 years
Survival Rate
Survival rate was defined as the time from randomization to 12month, the rate of participants who were alive at the time in total.
Time frame: 12 months
Clinical Benefit Response (CBR)
CBR is percentage of participants with best (confirmed) PR or CR or SD for at least 6 months. PR or CR or SD is according to RECIST version 1.1.
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500mg
Time frame: 2 months
Adverse Events (AEs)
AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. In general, AEs are graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE. The type, grade and frequency of AEs will be reported.
Time frame: Up to 3 years