breast cancer
Conditions
Interventions
Initial treatment group with brain metastases:RC48+pyrotinib
Progression group after radiotherapy for brain metastases:RC48+pyrotinib
Sponsors
Tianjin Cancer Hospital Airport Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily agree to participate in the study and sign the informed consent; 2. Aged 18-70 years (including 18 and 70 years), subjects who have not reached the 71st birthday are considered to be =6 months; 4. ECOG PS score 0 or 1; 5. For female subjects: should be surgically sterilized, postmenopausal, or consent to use a medically approved contraceptive (such as an intrauterine device, contraceptive, or condom) during the study treatment period and for 6 months after the study treatment period; Blood pregnancy tests must be negative within 7 days prior to study administration and must be non-lactation. For male subjects: should be surgically sterilized or agree to use a medically approved contraceptive during the study treatment period and for 6 months after the study treatment period ends; 6. After fully understanding and signing the informed consent, subjects should voluntarily join the study. Subjects need to have good compliance and be willing to cooperate with follow-up; 7. Bone marrow function: hemoglobin >= 9 g/dL; Absolute neutrophil count >= 1.5x10^9/L; Platelet >= 100 x10^9/L; 8. Liver function (based on the normal value of clinical trial center) : serum total bilirubin = 50 mL/min calculated by Cockcrod-Gault formula; 10. Cardiac function: New York College of Cardiology (NYHA) grade = 50%; 12-lead ECG: QT interval corrected by Fridericia was = 2 cycles); 14. Previous (new) adjuvant therapy, relapse-metastasis treatment with trastuzumab or its biosimilar (single-agent therapy or in combination with other drugs, >= 3 months if used in adjuvant therapy, >= 6 weeks if used in neoadjuvant or relapse-metastasis); 15. Subjects treated with pyrrotinib or T-DM1 after 2 lines of standard therapy should progress for at least 6 months (metastatic disease) or 12 months (adjuvant therapy) after discontinuation of therapy. Simultaneous use of bisphosphonates, mannitol, and glucocorticoids is permitted provided that the glucocorticoid dose (2 mg of dexamethasone per day (or equivalent) remains stable for at least one week prior to registration; 16. Progression of unresectable locally advanced or metastatic breast cancer after the last systemic treatment (as confirmed by the investigator), or intolerance to the last systemic treatment; 17. (1) Subject group cohort A: Subjects with untreated CNS lesions >=1.0 cm (BMS who have not received prior CNS radiation therapy) should be treated at least 2 weeks a
Exclusion criteria
Exclusion criteria: 1. Patients who had received chemotherapy, molecular targeted therapy, palliative radiotherapy for bone metastases within 2 weeks prior to enrollment, and patients who had received endocrine therapy within 1 week prior to enrollment; 2. Minor operations, such as tumor biopsy, pleural puncture or intravenous catheter puncture, were allowed if major operations were performed within 4 weeks before the start of study administration and did not recover completely; 3. Received a live vaccine within 4 weeks prior to the start of study administration or planned to receive any vaccine (other than the novel coronavirus vaccine) during the study period; 4. Participate in other clinical trials within 4 weeks before enrollment; 5. Study the occurrence of arteriovenous thrombosis within 1 year before administration, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; 6. Suffering from uncontrolled systemic diseases, including diabetes mellitus, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, liver cirrhosis, etc.; 7. History of severe heart disease, including myocardial infarction and heart failure; Other heart conditions for which participation is not appropriate (as assessed by the investigator); 8. Having an active infection requiring systemic treatment; 9. History of active tuberculosis and positive HIV test result; 10. Patients with active hepatitis B or C (HBsAg positive with HBV DNA positive; HCVAb positive); 11. Known hypersensitivity or delayed allergic reactions to RC48, certain components of pyrrotinib or similar agents; 12. There are known gastrointestinal diseases that affect absorption, such as ileus, ulcerative colitis, chronic diarrhoea; Inability to swallow and other conditions affecting the administration and absorption of medications; 13. There are known mental or substance abuse disorders that may affect compliance with test requirements; 14. Any other disease, metabolic abnormality, abnormal physical examination, or abnormal laboratory test that, in the investigator's judgment, has reason to suspect that the patient has a disease or condition that is not suitable for the use of the study drug, would affect the interpretation of the study results, or would put the patient at high risk; 15. Pregnant or lactating patients or patients trying to give birth; 16. Patients whose compliance to participate in the clinical study is estimated to be insufficient or who have other factors deemed unsuitable for participation in the study by the researcher; 17. Patients with flexural metastases (radiographic diagnosis/positive CSF cytology) or clear indications of clinically significant flexural meninges involvement; 18. Other malignant tumors (non-melanoma skin cancer, carcinoma in situ of the cervix or other tumors that have been effectively treated, except malignant tumors that are considered cured) within 5 years prior to the signing of the informed consent form; 19. Central nervous system complications requiring emergency neurosurgical intervention (e.g. excision, shunt placement). BMS with poor response to dehydration therapy and glucocorticoid therapy. Such as uncontrolled increased intracranial pressure, jet vomiting, mental disorders, epilepsy, cognitive impairment, etc. 20. Patients who had used pyrorotinib within 6 months before the start of the study, or who had not responded to previous treatment with pyrotinib (including progress with
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central nervous system (CNS) objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Progression-free survival (PFS);Non-CNS ORR;CNS disease control rate (CNS-DCR);Non-CNS DCR;Safety; | — |
Countries
China
Contacts
Public ContactLu Ning
Tianjin Cancer Hospital Airport Hospital
Outcome results
None listed