Breast Cancer
Conditions
Interventions
Experimental Group:Posaconazole combined with neoadjuvant chemotherapy and PD-1 inhibitors
Control group:Neoadjuvant chemotherapy and PD-1 inhibitors
Sponsors
Cancer Hospital of Shandong First Medical University (Shandong Cancer institute, Shandong Cancer Hospital)
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any procedures related to the trial 2. Female, age 18 or older, 70 or younger 3.ECOG PS 0-1 4. Pathologically confirmed primary single-focal invasive breast cancer: (1) Tumor staging: cT1cN1-3M0 or cT2-4N0-3M0, TNM staging refer to the Eighth Edition AJCC Cancer Staging Manual (2) HER2 negative: defined as IHC0 or IHC1+ or IHC2+ and FISH- (3) Estrogen receptor (ER) and progesterone receptor (PR) negative: =90g/L b) Neutrophils (ANC) >=1.0×109/L c) Platelet (PLT) >=75×109/L (2) No functional organic disease, must meet the following criteria: a) Serum total bilirubin 1.5 ULN) b) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =40ml/min and Cr > 1.5xULN e) Urinary protein =2+, the 24-hour urinary protein must be <2g, or the urinary protein-creatinine ratio (UPC) must be <2 f) International Standardized ratio (INR), activated partial thromboplastin time (aPTT) : <=1.5×ULN
Exclusion criteria
Exclusion criteria: 1. Stage IV metastatic breast cancer 2. Inflammatory breast cancer 3. Bilateral primary breast cancer (including invasive and in situ cancer) 4. Previous antitumor therapy or radiation therapy for any malignancy, excluding cervical carcinoma in situ, skin basal cell carcinoma, and squamous cell carcinoma that have been cured 5. Receive any sex hormone therapy (such as birth control pills, ovarian hormone replacement therapy, etc.), or any hormone medication (such as raloxifene, tamoxifen, or other selective estrogen receptor toner) for osteoporosis or breast cancer prevention 6. Patients who had undergone a major surgical procedure unrelated to breast cancer within 4 weeks prior to randomization or who had not Full recovery 7. CTCAE 5.0 grade evaluation for symptomatic peripheral neuropathy = grade 2 8. Serious cardiovascular and cerebrovascular diseases, including but not limited to: A history of congestive heart failure or systolic dysfunction (LVEF470ms (4) Clinically significant valvular heart disease with impaired heart function (5) Clinically uncontrollable hypertension (6) History of myocardial infarction 9. Allergic to any component of any drug in this program 10. People who are not suitable for corticosteroids 11. People with active infection who currently require systemic anti-infective treatment 12. History of immunodeficiency, including HIV positive test, or other acquired, congenital immunity Disease defects, or a history of organ transplantation 13. Participants who had participated in another interventional drug clinical trial or concurrently participated in another within 28 days prior to randomization A clinical trial or other investigational treatment 14. Pregnancy (pregnancy test positive), breastfeeding patients 15. Any other comorbidities that interfere with the implementation of the treatment regimen, or subjects with a history of other serious systemic diseases that the investigator deems unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total pathological complete response;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Breast pathological complete response;3-year event-free survival rate;Survival rate;Security; | — |
Countries
China
Contacts
Public ContactQiu Pengfei
Cancer Hospital of Shandong First Medical University (Shandong Cancer institute, Shandong Cancer Hospital)
Outcome results
None listed