Breast cancer
Conditions
Interventions
Intervention group:Sacituzumab Govitecan,?Anlotinib Hydrochloride
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female, aged >=18 years and =1.0 cm according to RANO-BM criteria). CT scan cannot substitute for brain MRI. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 6. Life expectancy >=12 weeks. 7. Adequate organ function and bone marrow function (without transfusion, recombinant human thrombopoietin, or colony-stimulating factor therapy within 2 weeks prior to the first dose): * Hematological: Absolute neutrophil count (ANC) >=1.5 × 10^?/L; Platelets (PLT) >=100 × 10^?/L; Hemoglobin >=9 g/dL. * Hepatic Function: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) =3 g/dL.,3) Renal function: Creatinine clearance >=50 mL/min (calculated by the Cockcroft-Gault formula); 4) Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) <=1.5 × upper limit of normal (ULN); 8. For female subjects of childbearing potential, use of effective medical contraception from the time of signing the informed consent form until 6 months after the last dose; 9. The subject voluntarily agrees to participate in this study and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects who have had another known, progressing, or actively treated malignancy within the past 5 years. Exceptions include cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma that has undergone potentially curative therapy, or carcinoma in situ of the cervix. 2. Patients with poorly controlled hypertension despite antihypertensive therapy (systolic blood pressure>=150 mmHg or diastolic blood pressure >=100 mmHg). 3. Patients presenting with grade 2 or higher myocardial ischemia, myocardial infarction, arrhythmia (including QT interval >=480 ms), or cardiac function classified as NYHA class III–IV. 4. Patients with clinically uncontrolled pleural effusion/ascites (subjects who do not require drainage or whose effusion does not significantly increase within 3 days after discontinuing drainage may be enrolled). 5. Imaging shows tumor lesions 325 mg), or nonsteroidal anti-inflammatory drugs to inhibit platelet function within 10 days prior to enrollment, or treatment with dipyridamole, ticlopidine, clopidogrel, or cilostazol. 8. History of gastrointestinal bleeding due to severe portal hypertension or a clear predisposition to such bleeding, or a clear predisposition to gastrointestinal bleeding due to other reasons (e.g., active ulcers, ulcerative colitis, etc.). Subjects with severe and/or uncontrolled concurrent diseases, such as decompensated liver cirrhosis. 9. Nephrotic syndrome, uncontrolled metabolic disorders, active inflammatory bowel disease, or gastrointestinal perforation. 10. Subjects with known poorly controlled human immunodeficiency virus (HIV) infection, including HIV-infected individuals with a history of Kaposi's sarcoma and/or multicentric Castleman disease. 11. Subjects who have undergone major surgery (as defined by the investigator) within 30 days prior to the first dose of study treatment or are still in the recovery period from a previous surgery. 12. Subjects with known allergy or hypersensitivity to the study drug or its excipients. 13. Subjects who have previously received TROP2 ADC therapy or any antibody-drug conjugate (ADC) containing a topoisomerase I inhibitor. 14. Subjects who have received a live vaccine within 30 days prior to the first dose of study treatment or plan to receive a live vaccine during the study period. 15. Subjects who require the use of strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks prior to the first dose of study treatment or during the study period. 16. Subjects who have received palliative radiotherapy to known brain metastasis sites within 4 weeks prior to the first dose of study treatment. 17. Subjects who have received systemic anti-infective therapy within 1 week prior to the first dose of study treatment. 18. Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of corneal conditions that prevent/delay corneal healing. 19. Any other condition deemed by the investigator to make the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate of CNS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS;Overall survival,;Disease control rate, DCR;Duration of remission, DOR; | — |
Countries
China
Contacts
Public ContactWen-Ming Cao
Zhejiang Cancer Hospital
Outcome results
None listed