HER2-positive advanced breast cancer with brain metastasis
Conditions
Interventions
Ruikang Trastuzumab monotherapy group:Ruikang Trastuzumab: 4.8 mg/kg, intravenous infusion on the first day of each cycle.
14/1000 The Trastuzumab Combined with Radiotherapy Treatment Group:Trastuzumab: 4.8 mg/kg intravenously on the first day of each cycle
Radiation Therapy: Administered based on intracranial efficacy evaluated by RANO-BM criteria to determine timing. During trastuzumab treatment, intracranial efficacy is assessed every two cycles. If C
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. ECOG score = 1.0 × 10^9/L; PLT >= 100 × 10^9/L; Hb >= 90 g/L b) Blood biochemistry: TBIL = 50 mL/min (Cockcroft-Gault formula); c) Cardiac echocardiography: LVEF >= 50%; d) 12-lead electrocardiogram: QTcF corrected by Fridericia method for males < 450 ms, for females < 470 ms. 10. Voluntarily participated in this study, signed the informed consent form, had good compliance and was willing to cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Subjects with known leptomeningeal metastasis are defined as those diagnosed by imaging or with positive cerebrospinal fluid cytology, or with clear indications of clinically significant leptomeningeal involvement; 2. Complications of the central nervous system requiring urgent neurosurgical intervention (such as resection, shunt tube insertion); or subjects with brain metastases whose hormone diuresis treatment and hormone therapy are ineffective, such as uncontrollable intracranial hypertension, projectile vomiting, mental abnormalities, epilepsy, cognitive impairment, etc.; 3. Subjects with signs of tumor invasion into major blood vessels (those whose tumors are completely close to, encircle or invade the inner cavity of major blood vessels (such as pulmonary artery or superior vena cava)); 4. Subjects who had other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin; 5. Subjects with third-space effusion that cannot be controlled by drainage or other methods (such as large pleural effusion and ascites); 5. There are third-space effusions that cannot be controlled by drainage or other methods (such as large amounts of pleural effusion and ascites); 6. Have previously used or are currently using antibody-drug conjugates containing topoisomerase 1 inhibitors (including DS-8201a, etc.); 7. Are concurrently receiving other anti-tumor treatments; 8. Have received anti-tumor radiotherapy or surgery within 2 weeks prior to enrollment (minor surgeries such as tumor biopsy, thoracic puncture, or venous catheter insertion are allowed); have received endocrine therapy within 1 week prior to enrollment; have received anti-tumor chemotherapy, targeted drug treatment or immunotherapy before enrollment, and the last administration was less than 2 weeks or 5 half-lives (whichever is shorter) from the first study administration; 9. Have participated in other new drug clinical trials within 4 weeks prior to enrollment; 10. Have known hereditary bleeding tendencies or coagulation disorders; 11. Have or have had poorly controlled heart diseases or clinical symptoms, such as NYHA class II or above cardiac insufficiency; unstable angina pectoris; myocardial infarction within 1 year; supraventricular or ventricular arrhythmias requiring treatment or intervention; and any other heart diseases judged by the subject as not suitable for part; 12. Subjects who have had clinically significant pulmonary diseases, including but not limited to interstitial pneumonia, pneumonia, pulmonary fibrosis and radiation pneumonia (excluding radiological changes that do not require correction treatment), or those identified as having such diseases during the screening period; 13. Subjects with other factors that may affect study participation, increase study risks or interfere with study results, including but not limited to: 1) individuals with allergic constitution, or those with known allergic history to the components of the study drug; 2) history of immunodeficiency, including positive HIV test, or having other acquired or congenital immune deficiency diseases, or history of organ transplantation; 3) active hepatitis B (HBV DNA >= 500 IU/mL), hepatitis C (positive hepatitis C antibody and HCV RNA above the detection limit of the analytical method); 4) severe infections that require antibiotic, antiviral or antifungal drug control; 14. Pregnant or lactating female
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactMin Yan
Henan Cancer Hospital
Outcome results
None listed