Malignant Breast Tumor
Conditions
Interventions
Intervention Group:The patient is receiving Capecitabine (650 mg/m2, oral, twice daily), Anlotinib (12 mg, oral, once daily, taken continuously for 2 weeks, followed by a 1-week break), and Toripalima
Sponsors
Affiliated Hospital of North Sichuan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed locally advanced or metastatic triple-negative breast cancer (TNBC), with estrogen receptor (ER) less than 1%, progesterone receptor (PR) less than 1%, and HER2/FISH negative. 2. Patients have previously received no more than one line of standard chemotherapy. 3. Age between 18 and 75 years inclusive. 4. Eastern Cooperative Oncology Group (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. Patients have adequate baseline organ function. 8. Patients may have been previously exposed to anthracycline antibiotics and/or taxanes, including those who have been exposed to anthracyclines and/or taxanes in the adjuvant or neoadjuvant setting, or those who have failed treatment after receiving or completing chemotherapy with anthracyclines and/or taxanes, or those who are deemed unsuitable for anthracycline and/or taxane-based first-line treatment by the investigator's judgment. 9. Willing and able to sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Allergic to capecitabine, anlotinib, or toripalimab. 2. Previously treated with anlotinib or toripalimab. 3. History of active autoimmune disease or immunodeficiency. 4. Severe cardiac disease. 5. History of other active cancers, with diseases judged by the investigator to have visceral crisis. 6. Severe, concurrent, and/or uncontrollable diseases. 7. Expected survival of less than 12 weeks. 8. Pregnant or nursing women. 9. Patients planning to become pregnant during the study period. 10. Symptoms indicating central nervous system involvement. 11. Other conditions deemed by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival;Disease Control Rate;Safety and Tolerability; | — |
Countries
China
Contacts
Public ContactHou Lingmi
Affiliated Hospital of North Sichuan Medical College
Outcome results
None listed