Breast cancer
Conditions
Interventions
Experimental group:Adebrelimab combined with TCb-AC (albumin paclitaxel+carboplatin doxorubicin+cyclophosphamide)
Sponsors
Yuncheng Central Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: To be enrolled in the trial, participants must meet all of the following eligibility criteria: 1. Female patients aged >=18 years old and =1.5×10^9/L (without the use of hematopoietic stimulating factors within 14 days before the first dose of study drug); 2) White blood cell count >=3.0×10^9/L and =100×10^9/L (no blood transfusion within 14 days before the first study dose); 4) hemoglobin (Hb) >=90 g/L; (2) Blood biochemistry 1) TBIL=50 mL/min (Cockcroft-Gault formula); 5) INR and APTT =50%; 2) 12-lead ECG: QT interval, female < 470 ms. 7. The patients voluntarily participated and signed the informed consent form, and the compliance was expected to be good, and the patients could cooperate with the study according to the requirements of the protocol; 8. Women of childbearing age had a negative pregnancy test (serum or urine) within 7 days before enrollment and were required to voluntarily use an appropriate method of contraception during the observation period and for 4 months after the last dose of study medication.
Exclusion criteria
Exclusion criteria: If any of the following conditions occur, they are not selected as subjects: 1. Cancer-related symptoms and treatment; (1) patients with metastatic or bilateral breast cancer; (2) inflammatory breast cancer or occult breast cancer; (3) received any anti-tumor therapy, including chemotherapy, targeted therapy, radiotherapy, endocrine therapy, immunotherapy, biological therapy or tumor embolization within 12 months before signing the informed consent; (4) previous treatment with PD-1/PD-L1 antibody, CTLA-4 antibody, or other PD-1/PD-L1 inhibitor; 2. Comorbidities/medical history (1) patients with other active malignant tumors within 5 years before signing the informed consent form or at the same time. Localized tumors that have been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, and cervical cancer in situ, can be enrolled. Patients had undergone a major surgical procedure not related to breast cancer within 4 weeks before enrollment or had not fully recovered from such a surgical procedure (diagnostic biopsy and peripherally inserted central catheter [PICC] procedures were permitted); (3) subjects with any known or suspected autoimmune disease, except for: hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy; Subjects with stable type I diabetes with well-controlled blood glucose; (4) The presence of interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases (such as diabetes, pulmonary fibrosis, acute pneumonia, etc.); (5) vaccination history of live attenuated vaccine within 28 days before the first dose of study medication or expected vaccination during the study period; (6) human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); A positive test for hepatitis B virus surface antigen (HBsAg) or a positive test for hepatitis B core antibody (HBcAb) was performed (HBV-DNA testing was performed only in patients who tested negative for HBsAg and positive for HBcAb). A positive test for HCV-RNA after a positive test for HCV antibodies was performed (HCV-RNA testing was performed only in patients who tested positive for HCV antibodies). Autoimmune hepatitis; (7) Severe infection within 4 weeks before the first dose, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc.; Or the presence of active infection of CTCAE grade =2 requiring systemic antibiotic therapy within 2 weeks before the first dose, or unexplained fever >38.5°C during screening or before the first dose (fever due to cancer, as judged by the investigator, was eligible); Evidence of active tuberculosis infection within 1 year before administration; (8) subjects who have received or prepared to receive allogeneic bone marrow transplantation or solid organ transplantation; (9) peripheral neuropathy > grade 2; (10) serious cardiac disease or discomfort, including but not limited to the following: 1) a confirmed history of heart failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia) or higher grade AV block (i.e., Mobitz II second degree or third degree AV block) And 3) coronary artery disease requiring antianginal medication 4) clinically significant valvular heart disease 5) Transmural MI on ECG 6) Poorly controlled hypertension (systolic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total pathological complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Breast pathological complete response;The rate of breast conserving;Safety; | — |
Countries
China
Contacts
Public ContactZhaofeng Niu
Yuncheng Central Hospital,
Outcome results
None listed