Breast cancer
Conditions
Interventions
Dose group B:NC527-X: 0.01 mg/kg, administered by intravenous infusion 48 ± 6 hours before surgery
Dose group C:NC527-X: 0.02 mg/kg, administered by intravenous infusion 24 ± 6 hours before surgery
Dose group D:NC527-X: 0.02 mg/kg, administered by intravenous infusion 48 ± 6 hours before surgery
Dose group A:NC527-X: 0.01 mg/kg, administered by intravenous infusion 24 ± 6 hours before surgery
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign a written informed consent form; 2. Female participants aged 18 years or older; 3. Diagnosed with stage 0-III (see Appendix 1) primary invasive breast cancer, ductal carcinoma in situ (DCIS), or primary invasive breast cancer with a DCIS component, confirmed by imaging or pathology; 4. Planning to undergo breast-conserving surgery (BCS) combined with sentinel lymph node biopsy and/or axillary lymph node dissection; 5. ECOG score of 0-1; 6. Participants with potential for pregnancy must use effective contraception (e.g., oral contraceptives, intrauterine devices, etc.) during the study and continue contraception for 3 months after treatment completion; 7. Able to understand the procedures and methods of this study and willing to strictly adhere to the clinical trial protocol to complete the trial.
Exclusion criteria
Exclusion criteria: 1. History of allergy to similar products, contrast agents, or fluorescent lamps, or known allergy to the study drug and any other components; 2. Enrollment in another clinical study (including observational or non-interventional clinical studies) within 1 month prior to the first dose; 3. Vaccination with a live attenuated vaccine within 28 days prior to the first dose; 4. Major surgery (as defined by the investigator) within 1 month prior to the first dose; 5. Previous receipt of allogeneic stem cell or solid organ transplantation; 6. Adverse reactions due to prior treatment that have not recovered to CTCAE 5.0 Grade 1 or below within 28 days prior to the first dose (skin pigmentation, hair loss; adverse reactions assessed by the investigator as having no safety risk can be included); 7. Laboratory results during the screening period indicating that the subject does not have good organ function: (1) Hematology (exclude those who received blood transfusions and/or blood components or granulocyte colony-stimulating factor treatment within 14 days prior to screening laboratory tests) 1) Absolute neutrophil count 1.5 × ULN; for subjects with liver metastasis or evidence confirming/suspecting Gilbert's syndrome, TBil > 3 × ULN; 2) AST and ALT > 3 × ULN; for subjects with liver metastasis, AST and ALT > 5 × ULN; (3) Kidneys: Serum creatinine > 1.5 × ULN; or estimated glomerular filtration rate 1.5 × ULN (unless the subject is undergoing anticoagulant therapy and coagulation parameters (PT/INR and APTT) are within the expected range for those receiving anticoagulant therapy during screening); 8. Primary central nervous system tumors or symptomatic central nervous system metastases (meningeal metastases must be excluded regardless of symptoms); 9. Cardiovascular diseases that occurred within 6 months prior to the first medication include symptomatic heart failure classified as Grade 2 or higher by the American New York Heart Association (NYHA) (see Appendix 4), left ventricular ejection fraction (LVEF) 160 mmHg and/or the diastolic blood pressure >100 mmHg, and assessed by the investigator as clinically significant). Note: Exclusion is required if three 12-lead electrocardiograms suggest a QTc interval prolongation >470 milliseconds (ms) (females); atrial fibrillation or paroxysmal supraventricular tachycardia requiring treatment can be considered for inclusion if the condition is assessed by the investigator as stable; 10. Severe infections that occurred in the 4 weeks prior to the first medication or active infections within the last 2 weeks; 11. Infected individuals with the following conditions: Positive for human immunodeficiency virus antibodies (HIV-Ab); active hepatitis B virus infection [positive for hepatitis B surface antigen (HBsAg) and exceeding the upper limit for hepatitis B v
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity grades of adverse events (AEs) and serious adverse events (SAEs);Changes from baseline in physical examinations; | — |
Countries
China
Contacts
Public ContactLiu Tong
Harbin Medical University Cancer Hospital
Outcome results
None listed