Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy
A Prospective, Multi-cohort, Exploratory Phase II Study of Trilaciclib Combined With Standard Chemotherapy in The Adjuvant Treatment of Hormone Receptor (HR) Negative Breast Cancer
wang shusen
116 participants
Sep 20, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05978648