The aim of this study was to evaluate the progression time and efficacy of brain tumors in patients with brain metastases from HER2-positive breast cancer treated with Pyrrolidine and Capecitabine combined with brain radiotherapy.
Brain metastases are very common in HER2-positive breast cancer patients. The vast majority of patients with metastatic brain tumors are in advanced stages of the disease. If not treated in time, the natural course of the disease is extremely short. At present, the main treatment of brain metastases from breast cancer is radiotherapy, combined with chemotherapy and targeted therapy drugs. On the basis of previous clinical studies, the aim of this study was to explore the efficacy and safety of combined brachytherapy with Pyrrotidine and Capecitabine in patients with brain metastases from HER2-positive breast cancer, in order to provide a new, safer and more effective treatment for patients with brain metastases from breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
CAPECITABINE: 800 mg/m2 twice daily, taken orally within 30 minutes after meal (one in the morning and one in the evening, 12 hours apart, equal to a daily dose of 1600 mg/m2, with one dose in the morning and one dose in the morning) .
Brain radiation therapy: the dose and frequency of brain radiation therapy are determined by the doctor according to the patient's condition.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China
RECRUITINGTime of intracranial tumor progression
Objective to evaluate the intracranial tumor progression time of piratinib and capecitabine combined with brain radiotherapy for HER2 positive breast cancer patients with brain metastasis
Time frame: through study completion, an average of 1 year
Progression-free survival
Objective to evaluate the progression free survival (PFS) of pirotinib and capecitabine combined with brain radiotherapy in HER2 positive breast cancer patients with brain metastasis.
Time frame: through study completion, an average of 1 year
Objective remission rate
objective response rate (ORR) of pirotinib and capecitabine combined with brain radiotherapy in HER2 positive breast cancer patients with brain metastasis.
Time frame: through study completion, an average of 1 year
Duration of treatment effect
Duration of treatment effect (DCR) of pirotinib and capecitabine It refers to the time between the first assessment of CR or PR and the first assessment of PD (Progressive Disease) or death from any causecombined with brain radiotherapy in HER2 positive breast cancer patients with brain metastasis.
Time frame: throughout studythrough study completion, an average of 1 year
Disease control rate
Objective to evaluate the disease control rate of pirotinib and capecitabine combined with brain radiotherapy in HER2 positive breast cancer patients with brain metastasis
Time frame: throughout studythrough study completion, an average of 1 year
Clinical Benefit Rate
Objective to evaluate the clinical benefit rate of pirotinib and capecitabine combined with brain radiotherapy in HER2 positive breast cancer patients with brain metastasis
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Time frame: throughout studythrough study completion, an average of 1 year
Overall survival
Objective to evaluate the overall survival of piratinib and capecitabine combined with brain radiotherapy in HER2 positive breast cancer patients with brain metastasis
Time frame: through study completion, an average of 1 year
Graded healing assessment
Objective to evaluate the effect of pyrrolotinib and capecitabine combined with brain radiotherapy in patients with HER2 positive breast cancer with brain metastasis,The score of graded healing assessment was 0-4. The higher the score, the better the result
Time frame: through study completion, an average of 1 year