Trilaciclib in Combination With Anti-PD-1 Antibody and Chemotherapy in the Treatment of Locally Advanced Triple-negative Breast Cancer: A Prospective, Single-arm, Multicenter Phase II Clinical Study
Trilaciclib is a highly potent, selective, and reversible CDK4/6 inhibitor that protects bone marrow by protecting hematopoietic stem cells and progenitor cells (HSPCs) during systemic chemotherapy. The proliferation and differentiation of HSPCs are highly dependent on the CDK4/6 signaling pathway, and when exposed to the appropriate dose of treacilil, they will be blocked in the G1 phase of the cell cycle, thus avoiding the killing of cell cycle-specific chemotherapy drugs. This is an open, single-arm, multicenter Phase II clinical study. Newly diagnosed TNBC patients with T1c N1-2 or T2-4 N0-2 will be screened according to the inclusion criteria. Fifty patients meeting the inclusion criteria will sign informed consent letters and receive neoadjuvant therapy with Trilaciclib + anti-PD-1 antibody + Paclitaxel-albumin + carboplatin. To evaluate the synergistic effect of Trilaciclib on bone marrow protection and anti-tumor therapy.
• Patients fully understand and voluntarily participate in this study and sign the informed consent form.
• Age ≥18 and ≤75 years.
• Newly diagnosed TNBC with stage T1c N1-3 or stage T2-4 N0-3.
• Patients scheduled to receive neoadjuvant therapy.
• 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).
• No previous antitumor system therapy.
• ECOG (Eastern Cooperative Oncology Group) performance status of 0-1.
• Patients voluntarily joined the study with nice compliance.
• 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).