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

Launched by QIAO LI · Apr 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with triple-negative breast cancer (TNBC), which is a type of breast cancer that does not respond to certain hormonal therapies. The trial is testing a combination of a drug called Trilaciclib, an anti-PD-1 antibody, and chemotherapy to see if this combination can help protect the bone marrow during treatment and improve anti-cancer effects. The trial is currently recruiting participants who are newly diagnosed with TNBC and meet specific criteria, such as being between 18 and 75 years old and having measurable cancer lesions.

If you or a loved one decides to participate, you will receive neoadjuvant therapy, which means the treatment will occur before any surgery. This study aims to evaluate how well the treatment works and what side effects may occur. Participants will need to meet certain health requirements, including having good organ function and not having received any previous cancer treatments. It’s important to discuss with your healthcare team if you meet the eligibility criteria and to understand all aspects of the trial before deciding to participate.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients fully understand and voluntarily participate in this study and sign the informed 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 lymph node 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 weeks before 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 INR is 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 any intervention in adulthood were included; Patients with asthma requiring medical intervention with bronchodilators were not included).
• • 5. Patients are taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose \> 10mg/day of prednisone or other therapeutic hormone) 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) myocardial infarction within 1 year, (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
• • 9. Patients with active infection or unexplained fever during screening or prior to initial treatment \>38.5℃ (as determined by the investigator, the subject's fever due to the tumor can be enrolled).
• • 10. Live vaccine was administered less than 4 weeks before or possibly during the study period
• • 11. Patients have a known history of psychotropic substance abuse, alcohol abuse, or druggy use.
• • 12. Patients should be excluded if, in the investigator's judgment, the subjects have other factors that may cause the study to be terminated (other severe medical conditions requiring concomitant treatment, serious laboratory abnormalities, associated family or social factors, and other circumstances that may affect the safety of the subjects or the collection of data and samples).