Malignant Breast Tumor
Conditions
Interventions
Intervention Group:The patient is receiving Capecitabine: 500 mg orally, three times a day
Anlotinib (12 mg, orally, once daily, taken continuously for 2 weeks, followed by a 1-week break)
and Toripalimab (3 mg/kg, intravenous injection, once every 3 weeks)
radiotherapy (the local radiotherapy dose and schedule are individually tailored based on the tumor's location and size).
Sponsors
Affiliated Hospital of North Sichuan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically and radiologically confirmed metastatic Triple-Negative Breast Cancer (TNBC). 2. Failed or intolerant to at least one prior standard treatment regimen. 3. Age between 18 and 75 years inclusive. 4. ECOG performance status score of 0-2. 5. At least one measurable lesion, defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 6. Expected survival of at least 12 weeks. 7. The patient has adequate baseline organ function. 8. Normal blood routine and organ function: a) Absolute Neutrophil Count (ANC) =1.5×10^9/L b) Platelet Count (PLT) =100×10^9/L c) Hemoglobin (HGB) =9 g/dL d) Total bilirubin =1.5×Upper Limit of Normal (ULN) e) Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) =2.5×ULN (for patients with liver metastasis, =5×ULN) f) Serum creatinine =1.5×ULN or creatinine clearance =50 mL/min. 9. Willing and able to sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to the study drugs or their components. 2. Previous treatment with Anlotinib, Capecitabine, Toripalimab, or other PD-1/PD-L1 inhibitors. 3. Participation in another clinical trial of a drug within 4 weeks prior to study start. 4. History of active autoimmune disease or immune deficiency. 5. Active or uncontrolled serious infections, including tuberculosis. 6. Symptomatic central nervous system metastasis (such as brain edema, requiring steroid intervention, or brain metastasis). 7. Serious cardiovascular diseases within 6 months prior to study start (such as myocardial infarction, congestive heart failure, severe arrhythmia). 8. Major surgery within 28 days prior to study start or unhealed wounds. 9. History of other malignancies (except for cured basal cell carcinoma or cervical carcinoma in situ). 10. History of active autoimmune disease or autoimmune disease requiring systemic treatment. 11. Received live vaccines within 28 days prior to study start. 12. Pregnant or breastfeeding women. 13. Any other conditions deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival;Safety and Tolerability;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactHou Lingmi
Affiliated Hospital of North Sichuan Medical College
Outcome results
None listed