to evaluate the efficacy of toripalimab combined with chemotherapy after hifu induction in the treatment of early triple-negative breast cancer

Conditions: Breast Cancer; TNBC - Triple-Negative Breast Cancer

Summary: to investigate the efficacy and safety of terbinumab combined with chemotherapy (epirubicin + cyclophosphamide → nab-paclitaxel + carboplatin) in neoadjuvant therapy of triple-negative breast cancer after hifu.


Eligibility criteria:
inclusion criteria: 1. female patients aged ≥ 18 years who require a negative pregnancy test for premenopausal and perimenopausal patients and promise to take reliable contraceptive measures during treatment; 2. histopathologically confirmed breast cancer patients who are negative for estrogen receptor (er), progesterone receptor (pr), and her-2 by immunohistochemistry; positive pd-l1 expression in tumor cells (≥ 1%); 3. triple-negative breast cancer patients without distant metastasis; 4. according to the response evaluation criteria in solid tumors (recist) version 1.1, they have at least one evaluable target lesion; 5. ecog ps score: 0 - 1; 6. new york heart association (nyha) functional class i; 7. electrocardiogram without myocardial ischemia, echocardiography lvef \> 55%, cardiac markers: cardiac troponin i (ctni) and brain natriuretic peptide (bnp) test values within the normal range; 8. normal major organ function, meet the following criteria: wbc ≥ 4.0 × 10 9/l,neutrophil count (anc) ≥ 1.5 × 10 9/l; platelet ≥ 100 × 10 9/l; hemoglobin ≥ 10 g/dl; serum creatinine ≤ 1.5 × upper limit of normal (uln); aspartate aminotransferase (ast) ≤ 2.5 × uln; alanine aminotransferase (alt) ≤ 2.5 × uln; total bilirubin ≤ 1.5 × uln; serum creatinine ≤ 1.5 × uln; 9) the subject is able to understand the study procedures, voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with the follow-up. - exclusion criteria: 1. patients during pregnancy and lactation, women of childbearing age who refuse to take effective contraceptive measures during the study period; patients with peripheral nervous system disorders caused by diseases or those with a history of significant mental disorders and central nervous system disorders; 2. serious or uncontrolled infections that may affect the evaluation of study treatment or study results, including but not limited to: active hepatitis virus infection, human immunodeficiency virus (hiv) antibody positive, lung infection, etc.; 3. known allergy to the active ingredients or other components of the study drug or surgical contraindications; 4. in addition to cured basal cell carcinoma of the skin and cured cervical carcinoma in situ, other cancers are disease-free for less than 5 years; 5. severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, active gastrointestinal ulcers and other need treatment; 6. need to receive other anti-tumor therapy (except ovarian function inhibitors) during neoadjuvant therapy as judged by the investigator; 7. patients who are participating in other clinical trials within one month; 8. patients with severe heart disease or discomfort, expected intolerance to chemotherapy,including, but not limited to: a. fatal arrhythmia or higher grade atrioventricular block (second-degree type 2 \[mobitz 2\] atrioventricular block or third-degree atrioventricular block); b. unstable angina pectoris; c. clinically significant valvular heart disease; d. transmural myocardial infarction on electrocardiogram; e. uncontrolled hypertension; 9. any other condition that in the opinion of the investigator would make the patient inappropriate for participation in this study.