breast cancer
Conditions
Interventions
Experimental group:Trastuzumab deruxtecan (T-DXd/DS8201) at a dose of 5.4mg/kg every three weeks, in with a low dose of apatinib, administered orally at 250mg per day, once daily, taken 30 minutes aft
Sponsors
The Fifth Medical Center of the General Hospital of the People's Liberation Army of China
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged =18 years with recurrent metastatic breast cancer; 2. Histologically confirmed hormone receptor-positive, HER2-low expressing breast cancer (IHC or, and FISH negative). The definitions of hormone receptor positivity and HER2-low expression are in accordance with the guidelines of CSCO BC. If there are multiple tests, the most recent result will be taken as accurate or whichever the researcher deems beneficial for the participant. 3. Patients with locally advanced or metastatic breast cancer that is unresectable prior to enrollment, with at least one measurable lesion, or those with bone-only metastasis if there are no measurable lesions; 4. Patients who have undergone 1-2 lines of endocrine therapy for locally advanced or metastatic stages, with or without CDK4/6 inhibitors or other targeted therapies, and 0-1 lines of chemotherapy; 5. ECOG performance score of 0-2; 6. Absolute neutrophil count =1.5×10^9/L, platelets =100×10^9/L, hemoglobin =90g/L; 7. Expected survival time of =3 months; 8. Willing to participate in this clinical trial and to sign the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have undergone major surgery or significant trauma within 4 weeks prior to enrollment or are expected to undergo major surgery; 2. Patients with a known allergy to any component of the drugs used in this protocol; 3. Patients who have received radiotherapy within 4 weeks prior to enrollment; 4. Patients with active cerebral (meningeal) metastases during the screening period; 5. History of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 6. Uncontrolled significant cardiovascular diseases; history of clinically significant QT prolongation, or a QTc interval >450 ms during the screening period; 7. Liver function abnormality [total bilirubin >1.5 times the upper limit of normal; ALT/AST >2.5 times the upper limit of normal in patients without liver metastasis, ALT/AST >5 times the upper limit of normal in patients with liver metastasis], or kidney function abnormality [serum creatinine >1.5 times the upper limit of normal]; 8. Pregnant or breastfeeding women, or women of childbearing potential with a positive baseline pregnancy test; or patients of childbearing potential who are unwilling to use effective contraception during the study and for at least 8 weeks after the last dose of the drug; 9. Based on the judgment of the researcher, the presence of severe concomitant diseases that could endanger patient safety or affect the completion of the study (such as severe hypertension, diabetes, thyroid disease, active infection, etc.); 10. A clear history of neurological or psychiatric disorders, including epilepsy or dementia; or deemed by the researcher as unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objectve response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DOR;CBR;OS;safety; | — |
Countries
China
Contacts
Public ContactShaohua Zhang
The Fifth Medical Center of the General Hospital of the People's Liberation Army of China
Outcome results
None listed