TNBC patients with tumor non-response after neoadjuvant chemotherapy
Conditions
Interventions
Experimental Group:skb264 for Injection 4mg/kg Q2W + Toripalimab 3mg/kg Q2W, administered via intravenous infusion, for 4-6 treatment cycles
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.18 years old and above, female; 2.ECOG PS 0-1; 3. TNBC (early disease of T1c N1-2 or T2-4 N0-2) confirmed as operable based on histology and/or cytology, and meeting the following conditions simultaneously: a) negative human epidermal growth factor receptor 2 (HER2) : immunohistochemical (IHC) 0 or 1+; If the IHC is 2+, it is confirmed negative by fluorescence in situ hybridization (FISH). b) Estrogen receptor (ER) and progesterone receptor (PR) negative or weakly positive: IHC shows that = 1.2×109^/L; Platelet count (PLT) >=75×10^9/L; Hemoglobin >= 9 g/dL; b) Liver function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) = 60 ml/min (the Cockcroft-Gault formula is attached); d) Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) = 50%; 7. Patients with negative serum pregnancy tests and those with fertility potential must agree to use effective non-hormonal contraceptive methods during the treatment period and for at least 3 months after the last use of the test drug. 8. Voluntarily join this study, sign informed consent, have good compliance and be willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.. Patients with metastatic breast cancer (stage IV); 2. A history of major cardiovascular diseases such as baseline left ventricular ejection fraction (LVEF) <50% as assessed by echocardiography (ECHO) or multistage collection (MUGA) scans during screening, or ipsilateral invasive BC of Class III or IV myocardial diseases as described by the New York Heart Association; 3. Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L-2 or anti-CTLA-4 antibodies, or any other antibodies or drugs specifically targeting T-cell co-stimulation or checkpoint pathways; 4. Previously used treatments targeting TROP2 and/or topoisomerase I inhibitors; 5. Having suffered from other malignant tumors within the past five years, excluding cured cervical carcinoma in situ, cutaneous basal carcinoma or cutaneous squamous cell carcinoma; 6. It is known that there is a history of allergy to the drugs and their components in this protocol, a history of immune deficiency, or a history of organ transplantation; 7. There is a history of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment. Currently, there is ILD or non-infectious pneumonia, or there is suspected ILD or non-infectious pneumonia that cannot be ruled out by imaging examinations during screening. Clinical severe lung damage caused by concurrent pulmonary diseases, including but not limited to any underlying pulmonary diseases (such as pulmonary embolism within 3 months before administration, severe asthma, severe chronic obstructive pulmonary disease, restrictive pulmonary disease, pleural effusion, etc.) or any autoimmune, connective tissue or inflammatory diseases that may involve the lungs (i.e. Rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.) Or previous pneumonectomy; 8. Those who are active and have required systemic treatment in the past two years, such as type 1 diabetes, hypothyroidism that only requires thyroid hormone replacement therapy, or adrenal or pituitary insufficiency that only requires physiological dose glucocorticoid replacement therapy; 9. Active infections that require systemic treatment within 2 weeks prior to the first administration; 10. According to the researcher's judgment, there are serious concomitant diseases that seriously endanger patient safety or affect the patient's completion of the study, including but not limited to hypertension that cannot be controlled by drugs, severe diabetes, active infections, etc. 11. There is a confirmed history of severe dry eye syndrome, severe meibomian gland dysfunction and/or blepharitis, or a history of corneal diseases that hinder/delay corneal healing; 12. Any other circumstances in which the researchers consider the patient unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of adverse events (AE), serious adverse events (SAE), and adverse reactions of particular concern;ORR;RCB;DCR;DOR;EFS; | — |
Countries
China
Contacts
Public ContactFangmeng Fu
Fujian Medical University Union Hospital
Outcome results
None listed