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.
Myelosuppression is the cause of many cancer chemotherapy-related adverse events, such as infections, sepsis, bleeding, and fatigue, resulting in delayed hospital stays or the need for treatment with hematopoietic growth factors, blood transfusions, and so on. In addition, myelosuppression usually leads to a lower dose or more extended interval of chemotherapy, which reduces the intensity of chemotherapy and affects the benefit of chemotherapy for patients. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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;
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Beijing, China
RECRUITINGIncidence of ≥ grade 3 neutropenia during chemotherapy
Incidence of ≥ grade 3 neutropenia during chemotherapy. (neutrophil count ≤ 1\*10\^9/L)
Time frame: At the end of Cycle 1 (each cycle is 21days)
event-free survival
Time from randomization to occurrence of any event
Time frame: one year after the last dose
Duration of grade 3 or 4 neutropenia in the first treatment cycle of chemotherapy (days);
Duration of grade 3 or 4 neutropenia in the first treatment cycle of chemotherapy (days)
Time frame: From the initiation of the first dose to 28 days after the last dose
The incidence of grade 3 or 4 thrombocytopenia
The incidence of grade 3 or 4 thrombocytopenia (Platelet\<50×109/L)
Time frame: From the initiation of the first dose to 28 days after the last dose
The incidence of grade 3 or 4 anemia during chemotherapy treatment
The incidence of grade 3 or 4 anemia during chemotherapy treatment (HGB\<80g/L)
Time frame: From the initiation of the first dose to 28 days after the last dose
Incidence of adverse events (AES) and serious adverse events (SAEs)
The incidence of adverse events (AES) and serious adverse events (SAEs), and the incidence of AES/SAEs leading to treatment termination
Time frame: From the initiation of the first dose to 28 days after the last dose
pathologic complete response (pCR)
Proportion of patients with no residual invasive tumor cells on pathological examination of primary breast lesions and axillary lymph node surgical specimens of all patients
Time frame: At the end of Cycle 6-8 (each cycle is 21 days)
Utilization rate of Granulocyte colony stimulation (G-CSF)
Utilization rate of Granulocyte colony stimulation (G-CSF)
Time frame: From the initiation of the first dose to 28 days after the last dose
All-cause chemotherapy dose reduction rate.
All-cause chemotherapy dose reduction rate.
Time frame: From the initiation of the first dose to 28 days after the last dose
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