Breast cancer
Conditions
Interventions
Group A:Trastuzumab Rezetecan for Injection 4.8mg/kg,ivgtt,q3w
Group B:Trastuzumab Rezetecan for Injection 4.8mg/kg,ivgtt,q3w
pyrotinib 320mg po qd
Group C:Trastuzumab Rezetecan for Injection 4.8mg/kg,ivgtt,q3w
anlotinib 12mg po d1-14,q3w
Group D:Trastuzumab Rezetecan for Injection 4.8mg/kg,ivgtt,q3w
capecitabine 1000mg/m2 po d1-14,q3w
Sponsors
ChongQing university cancer hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Agree and sign the written informed consent form; 2. Female and male patients aged >= 18 years and = 1.5 × 10^9/L; platelets >= 100 × 10^9/L; hemoglobin >= 90 g/L; b) Liver function: total bilirubin = 50 mL/min (according to Cockcroft and Gault formula); d) Coagulation function: international normalized ratio (INR) = 2+, additional 24-hour urine protein quantification should be performed, if 24-hour urine protein = 50%; 11. Participants must be willing and able to comply with the protocol during the study period.
Exclusion criteria
Exclusion criteria: 1. Central nervous system complications requiring urgent intervention, or brain metastases with poor control of hormone or dehydration treatment symptoms, such as uncontrollable intracranial hypertension, mental disorders or epilepsy; 2. Previously used antibody-conjugated drugs containing epirubicin derivatives of topoisomerase I inhibitors (such as deruxtepruzumab), and disease progression occurred during treatment; 3. Previously used capecitabine and disease progression occurred during treatment; 4. Previously used anlotinib; 5. Known clinical significance pulmonary diseases, namely severe and moderate pulmonary diseases that significantly affect respiratory function, including but not limited to: idiopathic pulmonary fibrosis, pneumonia. Those with =3 grade interstitial lung disease are not eligible for enrollment; 6. Abnormal coagulation function, with a bleeding tendency (must meet INR within normal range without using anticoagulants within 14 days before medication); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; with INR 450 milliseconds [male] or > 470 milliseconds [female]); 10. Third space effusion that cannot be controlled by drainage or other methods (such as pleural effusion and ascites); 11. Severe uncontrolled internal medicine diseases or acute infections (fever above 38? caused by infection); 12. Unable to swallow, intestinal obstruction or other factors affecting drug administration and absorption; 13. Known allergy history to the components of the drug in this protocol; 14. History of immunodeficiency diseases, including positive HIV test, or having other acquired or congenital immune deficiency diseases, or a history of organ transplantation; 15. Previously had other malignant tumors within 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin; 16. Pregnant or lactating women, women with reproductive capacity and positive baseline pregnancy test, or fertile women who do not want to take effective contraceptive measures throughout the trial; 17. Patients with severe comorbidities, or other circumstances that the investigator considers not suitable for participation in this study; 18. Other situations considered unsuitable for participation in this trial by the investigator within 2 weeks before enrollment, such as poor compliance in other new drug clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central Nervous System - Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Central Nervous System - Progression-Free Survival;The double progression-free survival period evaluated based on the RANO-BM standard and the RECIST V1.1 standard;Duration of relief;Disease control rate;Overall survival ;Quality of life score;Adverse reactions; | — |
Countries
China
Contacts
Public ContactXiaohua Zeng
ChongQing university cancer hospital
Outcome results
None listed