Trilaciclib Combined With Anti-PD-1 Antibody and Chemotherapy in the Treatment of Locally Advanced TNBC
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
QIAO LI
50 participants
Jul 3, 2023
INTERVENTIONAL
Summary
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.
Eligibility
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Interventions
trilaciclib 240mg/m2 ivgtt d1 Q3w; anti-PD-1 antibody 200mg ivgtt d1 Q3w; Paclitaxel-albumin 250mg/m2 ivgtt d1 Q3w or 125mg/m2 ivgtt d1,d8 Q3w; carboplatin AUC=5 ivgtt d1 Q3w; Review every 2 cycles until the best efficacy or intolerable toxicity, usually 6-8 cycles;
Locations(1)
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NCT06955156