Trilaciclib Combined With Anti-PD-1 Antibody and Chemotherapy in the Treatment of Locally Advanced TNBC

Inclusion Criteria:

1. Patients fully understand and voluntarily participate in this study and sign theinformed consent form.

2. Age ≥18 and ≤75 years.

3. Newly diagnosed TNBC with stage T1c N1-3 or stage T2-4 N0-3.

4. Patients scheduled to receive neoadjuvant therapy.

5. Patients have measurable lesions (non-lymph node lesions ≥10 mm in length and lymphnode lesions ≥15 mm in length according to RECIST 1.1 standards).

6. No previous antitumor system therapy.

7. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1.

8. Patients voluntarily joined the study with nice compliance.

9. Good organ function (no blood transfusion or growth factor support within 2 weeksbefore the first dose of trial medication): WBC≥3.0×10^9/L, ANC ≥1.5×10^9/L, PLT ≥75×10^9/L, Hb≥90g/L, ALP≤5×ULN, ALT≤3×ULN, AST≤3×ULN, ALB≥28 g/L,Creatinine≤1.5×ULN or Creatinine clearance ≥50 mL/min, INR≤1.5 /PT≤1.5×ULN,aPTT≤1.5×ULN (If patient is receiving anticoagulant therapy, as long as the PT INRis within the prescribed range of anticoagulants).

Exclusion Criteria:

1. Pathological diagnosis of HR+ or HER2+ breast cancer.

2. Imaging shows metastatic breast cancer.

3. Previous or current concurrent malignancy other than breast cancer.

4. Patients had any active autoimmune disease or a history of autoimmune disease (e.g.,but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis,hepatitis, pituitary vasculitis, nephritis, hyperthyroidism; Patients had vitiligo;Patients who had complete remission of asthma in childhood and without anyintervention in adulthood were included; Patients with asthma requiring medicalintervention with bronchodilators were not included).

5. Patients are taking immunosuppressants or systemic hormone therapy forimmunosuppressive purposes (dose > 10mg/day of prednisone or other therapeutichormone) and continued use within 2 weeks prior to enrollment.

6. Recurrence after surgery, previous local or systemic antitumor therapy.

7. Patients are known to have a prior allergy to the drug ingredient being applied.

8. Patients with poorly controlled cardiac clinical symptoms or diseases, such as (1)NYHA2 or higher heart failure, (2) unstable angina pectoris, (3) myocardialinfarction within 1 year, (4) Clinically significant supraventricular or ventriculararrhythmias requiring treatment or intervention.

9. Patients with active infection or unexplained fever during screening or prior toinitial treatment >38.5℃ (as determined by the investigator, the subject's fever dueto the tumor can be enrolled).

10. Live vaccine was administered less than 4 weeks before or possibly during the studyperiod

11. Patients have a known history of psychotropic substance abuse, alcohol abuse, ordruggy use.

12. Patients should be excluded if, in the investigator's judgment, the subjects haveother factors that may cause the study to be terminated (other severe medicalconditions requiring concomitant treatment, serious laboratory abnormalities,associated family or social factors, and other circumstances that may affect thesafety of the subjects or the collection of data and samples).