Breast cancer
Conditions
Interventions
Experimental group:Albumin paclitaxel (260mg/m2, q3w)+ Carbolplatin(AUC=5, q3w)+ AK112(20mg/Kg, q3w)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Enrolled patients must meet the following criteria: 1. Volunteer to participate in this clinical trial, sign a written informed consent form, understand this study and be willing to follow all trial procedures; 2. Female, age >=18 years old and =1.5×10^9/L, platelets (PLT)>=90×10^9/L, hemoglobin (Hb)>=90g/L; b) Total bilirubin (TBIL) 50 mL/min; c) Left ventricular ejection fraction (LVEF) >=50%, QT interval (QTcF) corrected by Fridericia's method <470 msec; d) INR<=1.5 times ULN, activated partial thromboplastin time (APTT) <=1.5 times ULN 8. Negative baseline pregnancy test test for pregnant, lactating female patients or women of childbearing potential; Subjects of childbearing age who are willing to use effective contraception during the study and for at least 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Received systemic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, radiotherapy, immunotherapy, targeted therapy (small molecule targeted therapy is within 2 weeks before enrollment), biologics therapy, etc.; Palliative local treatment within 2 weeks prior to enrollment; Received systemic non-specific immunomodulatory therapy (such as interleukin, interferon, thymuspeptide, etc.) within 2 weeks prior to enrollment; Received Chinese herbal medicine or proprietary Chinese medicine with anti-tumor indications within 2 weeks before enrollment; 2. Previous treatment with PD-1 monoclonal antibody or PD-L1 monoclonal antibody; 3. There is distant metastasis 4. Is participating in another clinical study, unless it is an observational, non-interventional clinical study or follow-up period of an interventional study; 5. Subjects have other malignant tumors within or at the same time in the past 5 years (except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and thyroid cancer); 6. Active autoimmune disease requiring systemic treatment (such as glucocorticoids, etc.) within 2 years before enrollment, or autoimmune disease that may recur or plan treatment in the judgment of the investigator. Except for: a) Skin diseases that do not require systematic treatment (e.g., vitiligo, alopecia, psoriasis, or eczema); b) Hypothyroidism caused by autoimmune thyroiditis requiring only a stable dose of hormone replacement therapy; c) Type I diabetes mellitus requiring only a stable dose of insulin replacement therapy; d) Asthma in childhood has been completely resolved without any intervention in adulthood; e) The disease is judged by the investigator to be non-recurring in the absence of external triggers 7. Received systemic anti-infective therapy (excluding antiviral therapy for hepatitis B or hepatitis C) within 2 weeks prior to enrollment; 8. Known presence of active pulmonary tuberculosis. Subjects with suspected active tuberculosis need to be examined on chest X-ray, sputum, and ruled out by clinical signs and symptoms; 9. Known active syphilis infection; 10. Active HBV and HCV infection; Except for those who are stable after drug treatment with hepatitis B (DNA titer shall not be higher than 500IU/mL or copy number 10mg/day prednisone or equivalent dose drugs) or other immunosuppressive drugs within 14 days prior to enrollment. Except for: a) Inhaled, ophthalmological, or topical glucocorticoids or other glucocorticoids at doses = 10mg/day prednisone or equivalent are allowed in the absence of active autoimmune disease. b) Physiologic dose of systemic glucocorticoids<= 10mg/day prednisone or equivalent dose of other glucocorticoids. c) Glucocorticoids as infusion-related reactions or allergic reactions (e.g., medication before CT examination, etc.). 14. Received a live vaccine within 30 days prior to enrollment or planned to receive a live vaccine during the study. 15. K
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological comlpete response; | — |
Countries
China
Contacts
Public ContactTing Luo
West China Hospital, Sichuan University
Outcome results
None listed