Stage II-III newly diagnosed triple negative breast cancer
Conditions
Interventions
Experimental group:SKB264 combined with Pembrolizumab
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~75 years old, gender is not limited; 2. Histologically or cytologically confirmed newly diagnosed stage II~III (T1cN1-2 or T2-4N0-2) TNBC breast cancer, defined as: immunohistochemistry (IHC) ER and PR=1.5x10^9/L in the absence of granulocyte colony-stimulating factor in the past 14 days; 2) Platelet >=100×10^9/L without blood transfusion in the past 14 days; 3) Hemoglobin > 9g/dL without blood transfusion or erythropoietic hormone use in the past 14 days; 4) total bilirubin =60 ml/min; 8) good coagulation, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; 9) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal limits. If baseline TSH is outside the normal range, if total T3 (or FT3) and FT4 are normal Subjects in the range may also be enrolled; 10) Cardiac enzyme spectrum within the normal range (if the investigator comprehensively judges that it is not clinically significant, simple laboratory abnormalities are also allowed to be enrolled); 7. Have not received any prior anti-tumor therapy for breast cancer; 8. For female subjects of childbearing potential and male subjects with partners of childbearing potential, those who voluntarily sign the informed consent form and take effective medical contraceptive measures within 6 months from the start of the informed consent form to the last dose; 9. Voluntarily participate in this study, sign the informed consent form, and be able to comply with the visits and related procedures specified in the protocol.
Exclusion criteria
Exclusion criteria: 1.Baseline left ventricular ejection fraction (LVEF) <50% assessed by echocardiography (ECHO) or multi-gated acquisition (MUGA) scan at screening, or major cardiovascular diseases including NYHA Class III or IV cardiomyopathy. 2.Prior chemotherapy, targeted therapy, and/or radiation therapy for currently diagnosed breast cancer before enrollment. 3.Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, or any antibody/drug specifically targeting T-cell co-stimulation or checkpoint pathways. 4.Prior Trop-2-targeted therapy and/or treatment with topoisomerase I inhibitors. 5.History of other malignancies within 5 years, except adequately treated cervical carcinoma in situ, basal cell carcinoma, or cutaneous squamous cell carcinoma. 6.Documented severe dry eye syndrome, severe meibomian gland dysfunction/blepharitis, or corneal diseases impairing delayed epithelial healing. 7.Known hypersensitivity to the investigational drug or its components. 8.History of immunodeficiency or organ transplantation. 9.(Non-infectious) interstitial lung disease (ILD) or pneumonitis requiring steroid therapy; current ILD/pneumonitis; suspected ILD/pneumonitis unresolved by imaging at screening; clinically significant pulmonary impairment including but not limited to: Underlying pulmonary diseases (e.g., pulmonary embolism within 3 months, severe asthma, severe COPD, restrictive lung disease, pleural effusion) Autoimmune/connective tissue/inflammatory diseases with pulmonary involvement (rheumatoid arthritis, Sjögren’s syndrome, sarcoidosis) Prior pneumonectomy. 10.Active autoimmune disease requiring systemic treatment within past 2 years (exceptions: hormone replacement, thyroxine replacement, physiologic glucocorticoid replacement). 11.Active infection requiring systemic therapy within 2 weeks prior to first dose. 12.Uncontrolled comorbidities jeopardizing safety/study completion per investigator judgment (e.g., uncontrolled hypertension, severe diabetes, active infection). 13.Any condition interfering with study drug evaluation, safety assessment, or data interpretation, or deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Countries
China
Contacts
Public ContactGuangdong Qiao
Yantai Yuhuangding Hospital
Outcome results
None listed