breast cancer
Conditions
Interventions
treatment group:intracranial fractionated stereotactic radiotherapy (SRT) combined with disitamabVedotin (RC48)
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily joined the study and signed informed consent; 2. Patients aged 18-75 years (calculated on the date of signing the informed consent, including the boundary value); 3. Patients must have pathologically confirmed HER2-positive breast cancer, defined as IHC 3+ or IHC 2+,FISH+, primary or metastatic tissue; 4. The patient must have at least one radiographically evaluable (RECIST1.1) brain metastatic lesion (intracranial measurable lesion larger than 10 mm) that may be combined/mixed with non-intracranial metastases; 5. The ECOG body status score of the patient was 0-2; 6. Functional level of major organs must meet the following requirements: Hb>=90 g/L; ANC>=1.5x10^9 /L; PLT>=75x10^9 /L; TBIL=50%; Fridericia corrected QT interval (QTcF) of 12-lead ECG =3 months.
Exclusion criteria
Exclusion criteria: 1. Patients with meningeal metastasis and hemorrhagic metastasis; 2. Patients with brain metastases who had previously received radiotherapy; 3. Any untreated intracranial diseases; 4. Patients with prior cancer, except the following patients: (1) Diagnosis before 5 years, during which time there is no evidence of disease recurrence; (2) Successfully treated basal cell or squamous cell skin cancers; (3) Cervical carcinoma in situ; 5. Having a medical or mental condition that impairs the ability to give informed consent or to complete the programme. Positive urine pregnancy test (in women with reproductive potential) (within 7 days of randomisation); 6. The patient was taking immunosuppressants and was still using them within 2 weeks prior to enrollment; 7. The patient has any active autoimmune disease or a history of autoimmune disease; 8. Patients infected with treponema pallidum, hepatitis C virus antibody, human immunodeficiency virus (HIV) positive; 9. Pregnant or lactating patients; Or women of childbearing age who tested positive for blood pregnancy during screening; 10. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Grade >2 for congestive heart failure; Ventricular arrhythmias requiring medical treatment; LVEF (left ventricular ejection fraction) 1.5 or partially activated prothrombin time (APTT) >1.5xULN) and bleeding tendency (such as active ulcer lesions in stomach, black stool and/or hematemesis within 3 months, hemoptysis); 15. Urine routine indicated urine protein >=2+, and 24-hour urine protein content >1.0g; 16. Correct QT interval > 470msec; If a patient has an extended QT interval, but the investigator's study estimates that the cause of the extension is a pacemaker (and no other cardiac abnormalities), the investigator determines whether the patient is eligible for enrollment; 17. Patients who have received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 18. Have or currently have idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, institutionalized pneumonia, drug pneumonia, or active pneumonia shown by CT during screening; 19. Any active infection requiring systemic treatment by intravenous drip occurs within 14 days prior to screening; 20. Those who have used radioactive agents (strontium, samarium, etc.) within 56 days prior to screening; 21. Receive live attenuated vaccine within 14 days prior to screening or planned for the study period; 22. Other conditions that may increase the risk associated with study medication, or interfere with the interpretation of study results, or affect the compliance of the study, etc., if the investigator determines that participation in the study is not appropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Extracranial response rate;Overall survival;Progression free survival in intracranial disease;Progression free survival in extracranial disease;Overall progression free survival;Neurocognitive function;Quality of life (QoL);Performance status;Death from intracranial causes; | — |
Countries
China
Contacts
Public ContactLin Peicheng
Fujian Cancer Hospital
Outcome results
None listed