Breast Cancer
Conditions
Interventions
experimental group:SNG1005 Experimental Treatment
control group:Investigator Assigned Physician’s Best Choice Control Treatment
Sponsors
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adults ( >= 18 years old); 2. Voluntarily sign the written informed consent, willing to cooperate with the research according to the requirements of the plan, and have good compliance; 3. Histologically or cytologically confirmed breast cancer subjects with negative HER2 expression (with confirmed HER2, ER and PR test results); 4. Expected survival time >= 2 months; 5. Newly diagnosed LC confirmed by imaging, cytology and/or neurology; 6. Previously received at least one course of radiation therapy due to brain parenchymal metastasis; 7. Subjects with neurological symptoms before the first administration can receive radiotherapy (SRS or FRT limited to symptom control) or intraventricular catheter shunt to reduce intracranial pressure, or stable doses of corticosteroids, radiotherapy and anticonvulsants Drugs (non-enzyme-inducing antiepileptic drugs, non-EIAED) treatment can participate in this trial after the neurological symptoms have stabilized for >= 1 week; 8. ECOG physical status score = 1.5 x 10^9/L; 2) Hemoglobin (Hgb) >= 90 g/L (no blood transfusion within 14 days); 3) Platelets (PLT) >= 100 x 10^9/L; (2) Blood biochemistry: 1) Total bilirubin = 50 mL/min (not corrected); 10. Female subjects of childbearing age must agree to use reliable contraceptive methods during the study and within 90 days after the last study treatment. Male partners of female subjects should use condoms during the study and for 90 days after the last study treatment.
Exclusion criteria
Exclusion criteria: 1. Previously received any anti-tumor therapy for LC (except for SRS or FRT for symptom control more than 1 week before the first medication); 2. WBRT has been performed within 4 weeks before the first administration; 3. Surgical resection for BM within 4 weeks before the first administration; 4. Chemotherapy (with nitrosourea or mitomycin within 6 weeks before administration), biological targeted therapy or immunotherapy within 4 weeks before the first administration; endocrine therapy within 2 weeks; 5. Have used P450CYP3A4 or 2C8 enzyme-induced antiepileptic drugs (EIAED) within 2 weeks before the first dose or used any other EIAED drugs within 2 weeks before the first dose; 6. Have taken St. John's wort or medicines containing its ingredients within 2 weeks before the first administration; 7. Previously received SNG1005 treatment; 8. Subjects with evidence of symptomatic intracranial hemorrhage assessed by the investigator; 9. Despite radiotherapy or shunt surgery, there is still evidence of increased intracranial pressure; 10. Subjects with intractable epileptic seizures; 11. The investigator believes that intrathecal injection therapy is the most appropriate first-line treatment for LC subjects; 12. Pregnancy or lactation; 13. Peripheral neuropathy > grade 2 (CTCAE version 5.0); 14. Evidence of any serious or poorly controlled disease (eg, unstable or decompensated breathing, heart (including arrhythmia), liver, kidney disease) assessed by the investigator; 15. Currently suffering from infection including abscess or fistula; 16. Currently suffering from severe or uncontrolled active hepatitis B or C or HIV-positive AIDS; 17. A history of interstitial lung disease (such as pneumonia or pulmonary fibrosis) within one year, or evidence of clinically significant interstitial lung disease found by chest CT scan; 18. Severe conduction disorders include clinically significant QTc prolongation >= 450 ms or QTc prolongation QTc prolongation >= 500 ms, regardless of whether the clinical symptoms are significant; 19. CNS diseases requiring immediate neurosurgery intervention; 20. Known severe hypersensitivity or allergic reaction to paclitaxel or any of its components; 21. Subjects who are contraindicated for enhanced whole brain and whole spinal cord MRI; 22. According to the investigator's judgment, the burden of extracranial lesions will have a greater impact on the effectiveness and safety evaluation of the test drug; 23. Other conditions that the investigator considers inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Clinical benefit rate;Overall survival rate;Objective response rate;Overall survival time of subgroup population;Duration of remission; | — |
Countries
China
Contacts
Public ContactXian Wang
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed