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Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy
Sponsor: wang shusen
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2023-09-20
Completion Date
2027-12-31
Last Updated
2023-11-30
Healthy Volunteers
No
Conditions
Interventions
Trilaciclib
240 mg/m2, intravenous drip over 30 min within 4 hours before chemotherapy administration on the same day
Epirubicin
90 mg/m2, intravenous drip, d1, Q3W, 4 cycles.
Cyclophosphamide
600 mg/m2, intravenous drip, d1, Q3W, 4 cycles.
Paclitaxel
80 mg/m2, intravenous drip, d1,8,15, Q3W, 4 cycles.
Docetaxel
75 mg/m2, intravenous drip, d1, Q3W, 6 cycles.
Carboplatin
area under curve(AUC) = 6, intravenous drip, d1, Q3W, 6 cycles.
Trastuzumab
8 mg/kg in Cycle 1, 6 mg/kg in subsequent cycles, intravenous drip, d1, Q3W, for 1 year.
Pertuzumab
840mg in Cycle 1, 420mg in subsequent cycles, intravenous drip, d1, Q3W, for 1 year.
Locations (1)
Sun-yat sen university cancer center
Guangzhou, Gangdong, China