Breast Cancer Patients with brain metastases
Conditions
Interventions
experimental group:SNG1005
control group:Single agent chemotherapy
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients (>= 18 years) who provide written informed consent. 2. Histologically or cytologically documented HER2-negative breast cancer (HER2, ER and PR status must be known and determined as per ASCO guidelines, refer to Appendix 6). 3. At least 3 months of expected OS. 4. At least one course of WBRT has been used in the past, and the current state is the progression of brain parenchymal disease. 5. At least one measurable target lesion of brain parenchymal metastasis (minimum diameter 1cm, and diameter perpendicular to the long diameter of the measurement plane should be >= 0.5cm). 6. Eastern Cooperative Oncology Group (ECOG) performance status grade = 1 week if a stable dose of corticosteroids and anticonvulsant drugs (non-enzymatically induced antiepileptic drugs (non-EIAED)) are received prior to the first dose. 8. Adequate laboratory test results for organ systems prior to first dose, as follows: a. Hematology Absolute neutrophil count (ANC)>= 1.5 x 10^9/L Hgb >= 9.0 g/dL Platelets >= 75 x 10^9/L b. Serum chemistry Total bilirubin = 50 mL / min (using the standard Cockcroft-Gault formula, refer to Appendix 2) 9. Male and female patients who are not surgically sterile or post-menopausal must agree to remain abstinent (refrain from heterosexual intercourse) or use reliable methods of birth control for the duration of the study and for 90 days after the last administration of study treatment. Male partners of female patients should use condoms for the duration of the study, and for 90 days after the last administration of study treatment.
Exclusion criteria
Exclusion criteria: 1. With BCLC (including: imaging and/or cerebrospinal fluid cytology suggesting suspicious or confirmed). 2. Surgical resection for BM within 4 weeks prior to the first dose. 3. Investigational agents or chemotherapy within 4 weeks or 5 half-lives prior to first dose, whichever is longer. 4. Chemotherapy (with nitrosourea or mitomycin for 6 weeks), biotargeted therapy or immunotherapy within 4 weeks prior to the first dose; endocrine therapy within 2 weeks. 5. Exposure to P450 CYP 3A4 or 2C8 enzyme inducing antiepileptic drugs (EIAEDs), or any EIAEDs within 2 weeks prior to first dose. 6. Have a history of other malignant tumors in the past 5 years, except for cured skin basal cell carcinoma and cervical carcinoma in situ. 7. Evidence of symptomatic intracranial hemorrhage assessed by the investigator. 8. There is still evidence of increased intracranial pressure. Except for evidence that subjects with increased intracranial pressure (CSF outflow obstruction or intractable seizures) have reduced intracranial pressure (eg, SRS or intraventricular reservoir or shunt) and stable seizures. 9. Pregnancy or lactation. 10. Peripheral neuropathy > Grade 2 (CTCAE v5.0). 11. Any evidence of severe or uncontrolled diseases (e.g., unstable or uncompensated respiratory, cardiac (including arrhythmias), hepatic and/or renal diseases), as assessed by the Investigator. 12. Patients with the presence of any infection including abscess or fistulae, or known infection with hepatitis B or C or HIV. 13. Interstitial lung disease within one year (e.g., pneumonitis or pulmonary fibrosis) or evidence of clinically significant interstitial lung disease on chest CT scan. 14. Severe conduction disturbance including clinically significant QTc prolongation >= 450 ms (unless pacemaker in place) or QTc prolongation >= 500 ms, regardless of clinical significance. 15. CNS disease requiring immediate neurosurgical intervention. 16. Known severe hypersensitivity or allergy to paclitaxel or any of its components. 17. Patients with a contra-indication for contrast-enhanced craniospinal MRI. 18. Other investigators believe that it is not appropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;ORR;DoR;QoL; | — |
Countries
China
Contacts
Public ContactWei Kai
Outcome results
None listed