Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy - Trial NCT05978648
Access comprehensive clinical trial information for NCT05978648 through Pure Global AI's free database. This Phase 2 trial is sponsored by wang shusen and is currently Not yet recruiting. The study focuses on Breast Neoplasms. Target enrollment is 116 participants.
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Study Focus
Sponsor & Location
wang shusen
Sun Yat-sen University
Timeline & Enrollment
Phase 2
Aug 01, 2023
Dec 31, 2027
Primary Outcome
Occurrence of Grade 3/4 neutropenia
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05978648
Non-Device Trial