The goal of this multicenter, two-cohort, exploratory clinical trial is to evaluate patients with early stage hormone receptor-negative breast cancer receiving standard adjuvant chemotherapy after surgery. The main question it aims to answer is: • The efficacy and safety of trilaciclib administered before standard adjuvant chemotherapy regimen using the incidence of grade 3/4 neutropenia as the primary efficacy endpoint. Participants will divide into two treatment cohorts according to molecular typing type: * Cohort A will be planned to include post-operative triple-negative breast cancer(TNBC) patients with lymph node positive or tumor \> 2 cm treated with trilaciclib combined with epirubicin and cyclophosphamide followed by weekly paclitaxel; * Cohort B will be planned to include HER2-positive/HR-negative breast cancer patients with axillary node positive or tumor \> 2 cm treated with trilaciclib combined with docetaxel, carboplatin and trastuzumab with or without pertuzumab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
240 mg/m2, intravenous drip over 30 min within 4 hours before chemotherapy administration on the same day
90 mg/m2, intravenous drip, d1, Q3W, 4 cycles.
600 mg/m2, intravenous drip, d1, Q3W, 4 cycles.
80 mg/m2, intravenous drip, d1,8,15, Q3W, 4 cycles.
75 mg/m2, intravenous drip, d1, Q3W, 6 cycles.
area under curve(AUC) = 6, intravenous drip, d1, Q3W, 6 cycles.
8 mg/kg in Cycle 1, 6 mg/kg in subsequent cycles, intravenous drip, d1, Q3W, for 1 year.
840mg in Cycle 1, 420mg in subsequent cycles, intravenous drip, d1, Q3W, for 1 year.
Sun-yat sen university cancer center
Guangzhou, Gangdong, China
RECRUITINGOccurrence of Grade 3/4 neutropenia
Proportion of subjects with at least one absolute neutrophil count (ANC) \< 1.0 × 10\^9/L enrolled and treated with at least one dose of trilaciclib
Time frame: Up to 24 weeks
Neutrophil-related myeloprotective effects
Occurrence of febrile neutropenia adverse events(AEs) , and occurrence of Granulocyte colony-stimulating factor(G-CSF) administration
Time frame: Up to 24 weeks
Red blood cell(RBC) -related myeloprotective effects
Occurrence of Grade 3/4 decrease of hemoglobin, occurrence and number of RBC transfusions on/after Week 5, and occurrence of erythropoiesis-stimulating agent(ESA) administration
Time frame: Up to 24 weeks
Platelet-related myeloprotective effects
Occurrence of Grade 3/4 decrease of platelets, occurrence and number of platelet transfusions, and occurrence of rhTPO/Recombinant human interleukin-11(rhIL-11) administration
Time frame: Up to 24 weeks
Myeloprotective Effects
Hospitalization due to chemotherapy-induced myelosuppression, dose reductions and delays, relative dose intensity(RDI) of chemotherapeutic agents
Time frame: Up to 24 months
Safety and tolerability
Incidence of Treatment-Emergent Adverse Events as per CTCAE version 5.0
Time frame: Up to 24 months
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