Breast Cancer
Conditions
Interventions
Study Group:Administer RC48 at a dose of 2 mg/kg based on the subject's weight. Dissolve it in sterile water for injection and dilute it in 250ml of normal saline for intravenous infusion every two we
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University.
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: In order to be included in this study, subjects must meet all of the following inclusion criteria: 1. Female patients aged =18 years and =75 years at initial diagnosis; 2. ECOG performance status 0-1; 3. Histologically confirmed invasive breast cancer meeting the following criteria: Early or locally advanced breast cancer (T1c-T2 and cN1-cN3 or T3-T4/cN0-cN3, M0) 4. Pathologically confirmed HER2 low expression (defined as immunohistochemistry [IHC] 2+, in situ hybridization [ISH]- or IHC 1+); 5. Known hormone receptor status (ER and PgR) and ER-positive (>10%); 6. Adequate organ function as defined by the following criteria (no transfusions or myeloid growth factors, or platelet transfusions within 2 weeks prior to screening): Hematology: neutrophil count (ANC) =1.5×10^9/L, platelet count (PLT) =100×10^9/L, hemoglobin (Hb) =90 g/L; Blood biochemistry: total bilirubin (TBIL) =1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =1.5×ULN, alkaline phosphatase (ALP) =2.5×ULN, blood urea nitrogen (BUN) (or urea) and creatinine (Cr) =1.5×ULN; 7. Echocardiography: left ventricular ejection fraction (LVEF) =55%; 8. For premenopausal or non-surgically sterilized female patients: agreement to practice abstinence or use effective contraceptive methods during the treatment period and for at least 6 months after the last dose of study treatment; 9. Voluntary participation in the study, signed informed consent, good compliance, and willingness to comply with follow-up.
Exclusion criteria
Exclusion criteria: Anyone with the following conditions will not be selected as a subject: 1. Stage IV breast cancer; 2. Pathological testing: HER2 0, 3+, or FISH/CISH+; 3. ER positive 180 mmHg and/or diastolic blood pressure >100 mmHg) 9. Known history of allergy to the drug components of this regimen; 10. History of immunodeficiency disease, including positive HIV test or acquired/congenital immunodeficiency disease, or organ transplant history; 11. Pregnant or lactating female patients, female patients with reproductive capacity and baseline pregnancy test positive, or reproductive-age patients who are unwilling to take effective contraceptive measures during the entire trial period; 12. Patients with severe concurrent illness or other comorbidities that may interfere with planned treatment, or any other conditions in which the investigator deems the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathology complete response (pCR) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate (ORR) ;QOL; | — |
Countries
China
Contacts
Public ContactQiang Liu
Sun Yat-sen Memorial Hospital, Sun Yat-sen University.
Outcome results
None listed