This study is a single-arm, exploratory clinical trial, aiming to include patients with HER2-positive advanced breast cancer. It intends to explore the efficacy and safety of trastuzumab combined with pyrotinib, capecitabine ± endocrine therapy as a first-line maintenance treatment for HER2+ advanced breast cancer after induction therapy with rucaparib trastuzumab. After the subjects meet the screening criteria and are enrolled, they receive induction therapy with rucaparib trastuzumab. Among them, patients without disease progression enter the maintenance treatment period and receive trastuzumab combined with pyrotinib, capecitabine ± endocrine therapy (±OFS) for treatment. Until disease progression, or toxicity becomes intolerable, or withdrawal of informed consent, or the investigator determines that the medication must be discontinued. During the study period, imaging evaluations are conducted according to the RECIST 1.1 standard, and the center assessment results are the final results. During the study period, the efficacy indicators such as PFS, ORR, DOR, CBR, and safety indicators of the subjects are evaluated according to the established trial standards, and statistical descriptions are conducted.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Administer intravenously at a dose of 4.8 mg/kg every 3 weeks (Q3W), with each 3-week period constituting one treatment cycle.
Take orally once daily, 400 mg each time.
Intravenous infusion: Initial dose 8mg/kg, subsequent dose 6mg/kg, 3 weeks as one cycle; Subcutaneous injection: Fixed dose 600mg (not based on the subject's weight), administration completed within 2-5 minutes, 3 weeks as one cycle.
Oral administration, 3 times a day, 500 mg each time
Administer the medication according to the recommended regimen specified in the doctor's instructions for endocrine therapy. For patients with HR-positive disease, they can choose to use
Fujian Cancer Hosptial
Fuzhou, Fujian, China
progression free survival(PFS)
The duration from the start of the induction period treatment to the observation of disease progression or the occurrence of death due to any cause.
Time frame: From enrollment to 3 years
objective remission rate(ORR)
The proportion of patients with a therapeutic response evaluated as Complete Response(CR) and Partial Response(PR)
Time frame: From enrollment to 3 years
duration of response(DoR)
It refers to the time period from the first evaluation as CR or PR (with the earlier occurrence taking precedence) until disease progression or death. The assessment is conducted using the RECIST 1.1 standard.
Time frame: From enrollment to 3 years
Clinical Benefit Rate(CBR)
The proportion of patients whose tumor volume has decreased by 30% or whose disease has remained stable (SD) for 24 weeks since the start of the assessment, which is the sum of the proportions of complete response (CR), partial response (PR), and disease stability (SD) maintained for 24 weeks as evaluated by the investigators based on the RECIST 1.1 standard.
Time frame: From enrollment to 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Through blood routine tests (such as hemoglobin, white blood cell count, neutrophil count, platelet count, etc.), liver and kidney function tests (such as albumin, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, urea nitrogen, creatinine, etc.), urine routine (such as urine protein, urine red blood cells, etc.), stool routine (stool occult blood), electrocardiogram (such as heart rate, QTc interval, etc.), echocardiography (left ventricular ejection fraction), etc., evaluate the changes in the values of corresponding tests during the treatment period. Classify and record the number of occurrences through CTCAE V5.0.
Time frame: From the time of enrollment until 30 days after the completion of the study
Overall Survival(OS)
The duration from the start of the induction period treatment to the observation of any cause-related death
Time frame: From enrollment to 3 years
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