triple-negative breast cancer (TNBC)
Conditions
Interventions
Experimental group:Iparomlimab and Tuvonralimab Combined with Albumin-bound Paclitaxel and Lobaplatin
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female breast cancer patients aged 18-75 years with a life expectancy >3 months; 2. Stage II-III TNBC confirmed by histology (specific definition: ER, PR negative defined as: immunohistochemistry detection ER 2 cm or nodal involvement (N+); 8. The level of organ function must meet the following requirements: (1) Hematology: a. Haemoglobin (HB) >= 9g / dL b. Neutrophil absolute value (ANC) >= 1.5 × 10^9 / L; c. Platelets (PLT) >= 100 × 10^9 / L; (2)Liver function: a. Total bilirubin (TBiL) = 60 mL / min (using the standard cockcroft-Gault formula) or serum creatinine = 50%; (5)12-lead ECG: QT interval < 480 ms; (6)Coagulation function: International standardized ratio (INR), activated partial coagulation APTT and PT <= 1.5 × ULN; 9. Female subjects of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptive pills or condoms) during the study period and within 6 months after the study. The serum pregnancy test should be negative within 7 days before study enrollment, and they must not be breastfeeding; 10.Willingness to participate voluntarily, provision of informed consent, adherence to study protocol, and cooperation with follow-up assessments.
Exclusion criteria
Exclusion criteria: 1. History of other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin; 2. Metastatic breast carcinoma (stage IV); 3. Patients with inflammatory breast cancer; 4. Histopathological diagnosis of breast neuroendocrine or metaplastic carcinoma; 5. Prior chemotherapy, radiotherapy, immunotherapy,or targeted therapy within the last 12 months; 6. Previous treatment with anti-PD-1, PD-L1, PD-L2, or other T-cell surface inhibitory receptor-targeting agents (e.g., CTLA-4, OX-40, CD137); 7. Concurrent administration of any other anti-neoplastic therapy; 8. Participation in another clinical trial with investigational drugs within 4 weeks prior to enrollment; 9. Receipt of live vaccines(including attenuated live vaccines) within 30 days before the first study drug administration; 10. Active autoimmune disease,except for vitiligo, hair loss, psoriasis or eczema that does not require systematic treatment; Hypothyroidism caused by autoimmune thyroiditis requires only stable doses of hormone replacement therapy (HRT) of the thyroid gland; Type I diabetes mellitus requiring only stable doses of insulin-replacement therapy; 11. 11. Receipt of systemic corticosteroids (>10 mg of prednisone or equivalent daily) or other immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-a inhibitors, etc.) within 30 days before the first study drug administration. Local use of corticosteroids, nasal sprays and inhaled corticosteroids is allowed. Systemic corticosteroids for the prevention of contrast agent allergy are also allowed; 12. 12. History of immunodeficiency, including those with Human Immunodeficiency Virus (HIV) infection; 13. Active hepatitis B (HBsAg positive and HBV-DNA >= 1000 copies/ml (200 IU/ml) or above the detection limit) can be enrolled in the study after stabilization after treatment. With the requirement that participants receive anti-hepatitis B virus therapy during the study period. Participants with active hepatitis C (HCV positive and HCV-RNA level above the detection limit); 14. Previous or current interstitial pneumonia/lung disease that requires systemic hormone therapy; 15. Active infections that require comprehensive treatment; 16. Severe cardiovascular disease, including myocardial infarction, acute coronary syndrome, or coronary interventions (percutaneous coronary intervention/stenting/bypass surgery) within the last 6 months, or New York Heart Association Class II-IV congestive heart failure or a history of Class III-IV congestive heart failure; 17. Known hypersensitivity to any component of the study medication or its analogs; 18. Pregnant or breastfeeding women, women of childbearing potential with a positive baseline pregnancy test, or women of reproductive age unwilling to use effective contraception throughout the study period; 19. History of significant neurological or psychiatric disorders, including epilepsy or dementia; 20. Any other condition deemed by the investigator as contraindicating participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total pathological complete response(tpCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Serious Adverse Event(SAE);Breast pathological complete response(bpCR);Overall survival (OS);Event Free Survival(EFS);invasive disease-free survival (iDFS);Objective response rate (ORR);Treatment-Related Adverse Event(TRAE);Adverse Events(AE); | — |
Countries
China
Contacts
Public ContactXaowei Qi
The First Affiliated Hospital of Army Medical University
Outcome results
None listed