This study aims to describe the different treatment time, treatment mode and clinical outcomes of pyrotinib maleate tablets combined with capecitabine in the treatment of patients with HER-2 positive advanced breast cancer with brain metastases.
This study is a multicenter, observational, real-world study with no formal statistical assumptions and sample size calculations; patient efficacy and safety data will be descriptively analyzed to assess the risk of HER2-positive advanced breast cancer patients with brain metastases. Efficacy of pyrotinib combined with capecitabine regimen in the real world, while evaluating the overall survival benefit of local therapy and drug therapy in patients with brain metastases. The estimated sample size is 300 cases, and at least one group of cohort A, cohort B and cohort C is planned to exceed 100 cases; Cohort A - patients with new brain metastases directly treated with pyrotinib combined with capecitabine; Cohort B- Whole brain radiotherapy or stereotactic radiotherapy concurrently (≤3 months before and after radiotherapy) with pyrotinib combined with capecitabine; Cohort C - group of patients with pyrotinib plus capecitabine after whole brain radiotherapy or stereotactic radiotherapy (more than 3 months after radiotherapy)。
Study Type
OBSERVATIONAL
Enrollment
300
Henan cancer hospital
Zhengzhou, Henan, China
RECRUITINGTime to Failure(TTF)
Time from initiation of study protocol treatment to treatment failure or study protocol discontinuation for any reason (including discontinuation due to patient request, disease progression, adverse events, or death)
Time frame: up to 2 years
Progression-free survival(PFS)
Time from initiation of study protocol treatment to disease progression (if occurring within 30 days of end of treatment) or death, as assessed by clinician or with or without radiographic progression.
Time frame: up to 2 years
CNS-DCR
The patients began to receive the treatment plan of this study, and during the period of the patients' disease progression group, the number of patients with the best response effect of intracranial lesions in the patient's medical records were objective remission (CR+PR) and stable disease (SD) in the analysis data set. The sum of the percentages of the total population.
Time frame: up to 2 years
CNS-CBR
The patient started to receive the treatment plan of this study, and during the period of the patient's disease progression group, the best response effect of intracranial lesions in the patient's medical records was complete remission (CR) + partial remission (PR) + stable disease (SD) ≥ 6 The sum of the month's patient population as a percentage of the total population in the analyzed dataset.
Time frame: up to 2 years
CNS-ORR
Among all patients who received pyrotinib plus capecitabine for brain metastases, the proportion of patients with physician-assessed complete remission (CR) or any less than complete remission (documented remission) in the patient's medical records on radiology scans.
Time frame: up to 2 years
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CNS-DOR
Duration between first scan showing documented remission of intracranial lesions and first scan showing disease progression or end of treatment if no progression occurred. rwDOR was evaluable in patients who received ≥2 consecutive radiology scans.
Time frame: up to 2 years
Overall Survival(OS)
The time from the start of treatment with this study protocol to the time of all-cause death of patients.
Time frame: up to 2 years
safety
Refers to the proportion of patients with a clinically significant adverse event (AE) (ie, leading to treatment modification or discontinuation, patient hospitalization, death, or permanent sequelae) documented in the medical records.
Time frame: up to 2 years