Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy
Status:
Recruiting
Trial end date:
2027-12-31
Target enrollment:
Participant gender:
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.