Primary invasive breast cancer at stage 0-III, ductal carcinoma in situ (DCIS), or primary invasive breast cancer with DCIS components
Conditions
Interventions
group D:NC527-X: 0.04 mg/kg, intravenous infusion 24–48 hours before surgery.
Dose Expansion Group:After completing dosing of 3 subjects in each group, the investigator and sponsor will conduct a dose expansion study in one dose group based on the e
group A:NC527-X: 0.005 mg/kg, intravenous infusion 24–48 hours before surgery.
group C:NC527-X: 0.02 mg/kg, intravenous infusion 24–48 hours before surgery.
group B:NC527-X: 0.01 mg/kg, intravenous infusion 24–48 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. Women aged 18 or above; 3. Diagnosed by imaging or confirmed by pathology, the patient has stage 0-III primary invasive breast cancer, ductal carcinoma in situ (DCIS), or primary invasive breast cancer with DCIS components; 4. It is planned to perform breast-conserving surgery (BCS) combined with sentinel lymph node biopsy and/or axillary lymph node dissection; 5. The ECOG score ranges from 0 to 1; 6. Subjects with childbearing potential must use effective contraceptive methods (such as oral contraceptives, intrauterine devices, etc.) during the trial and continue contraception for 3 months after the end of treatment. 7. Be able to understand the procedures and methods of this study, and be willing to strictly comply with the clinical trial protocol and complete the trial.
Exclusion criteria
Exclusion criteria: 1. Previous allergies to similar products, contrast agents, fluorescent lamps, or known allergies to the drug in this study and any other components; 2. Enroll in another clinical study (including observational or non-interventional clinical studies) within one month before the first administration; 3. The attenuated live vaccine was administered within 28 days before the first administration; 4. Having undergone major surgical operations within one month prior to the first administration (as defined by the researcher); 5. Have undergone breast lump resection surgery within 6 months prior to the first dose. 6. The subject has previously received allogeneic stem cell or solid organ transplantation; 7. Adverse reactions caused by previous treatments that have not recovered to CTCAE 6.0 standard grade 1 or below within 28 days before the first administration (adverse reactions such as pigmentation and alopecia, which the investigator assessed as having no safety risk, can be included); 8. Have laboratory test results during the screening period indicating that the subject does not have adequate organ function. 9. Patients with primary central nervous system tumors or symptomatic central nervous system metastases (those with leptomeningeal metastases should be excluded regardless of the presence or absence of symptoms). 10. Occurrence of any of the following cardiovascular diseases within 6 months prior to the first dose: symptomatic heart failure of New York Heart Association (NYHA) Class II or higher (see Appendix 4), left ventricular ejection fraction (LVEF) 160 mmHg and/or diastolic blood pressure > 100 mmHg after optimal antihypertensive treatment, and considered clinically significant by the investigator). Note: Subjects with a prolonged QTc interval > 470 ms (female) on three 12-lead ECGs must be excluded; patients with atrial fibrillation or paroxysmal supraventricular tachycardia requiring treatment may be considered for inclusion if assessed as stable by the investigator. 11. Occurrence of a serious infection within 4 weeks prior to the first dose, or an active infection within 2 weeks prior to the first dose. 12. Subjects infected with any of the following diseases: human immunodeficiency virus (HIV) infection; active hepatitis B virus infection [hepatitis B surface antigen (HBsAg) positive, with hepatitis B virus deoxyribonucleic acid (HBV-DNA) detection > 200 IU/mL or > 10³ copies/mL]; hepatitis C virus infection [positive for HCV antibodies and viral ribonucleic acid (HCV-RNA) test results]; or positive for Treponema pallidum antibodies. 13. Subjects with a positive pregnancy test during the screening period, who are breastfeeding, or who plan to become pregnant or conceive during the course of this trial. 14. Any other disease, medical condition or abnormality, metabolic dysfunction, physical examination findings, or clinical laboratory results that contraindicate the use of the investigational drug, may affect the interpretation of the results, or may place the subject at high risk for treatment complications, or any situation that, in the investigator's judgment, makes the use of the investigational drug inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| True Negative Rate;Proportion of patients with additional malignant tissue detected under the guidance of the fluorescence imaging system.;True Positive Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence and grades of adverse reactions (AE) and serious adverse reactions (SAE);Proportion of patients with successful localization of the primary lesion by NC527-X fluorescence.; | — |
Countries
China
Contacts
Public ContactLiu tong
Harbin Medical University Cancer Hospital
Outcome results
None listed