triple negative breast cancer
Conditions
Interventions
Study group:Neoadjuvant therapy using the original Chinese immune checkpoint inhibitor Triprolizumab (240mg) combined with albumin paclitaxel (250mg/m2) and carboplatin (AUC=5) (d1, Q3W) chemotherapy
Sponsors
Xuancheng People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with cT1N1-3 or T2-4N0-3M0 triple negative primary breast cancer confirmed by fine needle or hollow core needle biopsy pathology; 2. Age range from 18 to 70 years old (>= 18, = 10 mm in MRI scans and measurable skin nodules, If >= 10 mm, it can also be used as a measurable lesion; 4. ECOG score = 3.0 × 10^9/L. Hb >= 100g/L, ANC >= 1.5 × 10^9/L. PLT >=90 × 10^9/L; 2) TBIL <= 1.5 x upper limit of normal value, AKP, AST, and ALT <= 2.5 x ULN; 3) BUN <= 1.5 x ULN, Cr <=1.5 x ULN; 9. The patient agrees to undergo chemotherapy, immunotherapy, surgery, and other related treatments, and signs an informed consent form; 10. Should be surgical sterilization, postmenopausal patients, or agree to use it during the clinical study period and within 3 months after the end of the clinical study A medically recognized contraceptive measure, serum or urine pregnancy test must be negative and non lactating.
Exclusion criteria
Exclusion criteria: 1. Breast lesion biopsy confirmed as Her-2 (3+) or Her-2 (2+) positive through Fish testing and LuminalA And LuminalB type patients; 2. Accompanied with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc; 3. Has received chemotherapy, immunotherapy, and radiation therapy; 4. Simultaneously merging with other malignant tumors; Excluding cured skin basal cell carcinoma and cervical carcinoma in situ; 5. Patients during lactation and pregnancy; 6. Patients with mental illness or poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative pathological complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event free survival;Overall survival;safety and tolerability;Immune sensitive subtype; | — |
Countries
China
Contacts
Public ContactXie Hua
Xuancheng People's Hospital
Outcome results
None listed