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NCT05978648Not yet recruiting

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 shusenPhase 2ClinicalTrials.govdrug
Study focus
Disease/Condition
Breast Neoplasms
Drug/Device/Intervention
Trilaciclib
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
wang shusen
Funder
Sun Yat-sen University
Location
Guangzhou, China
Timeline & enrollment
Phase
Phase 2
Start date
Aug 01, 2023
End date
Dec 31, 2027
Enrollment
116 participants
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
Malignant neoplasm of breastMalignant neoplasm of breastMalignant neoplasm: Breast, unspecifiedBenign neoplasm of breastMalignant neoplasm: Central portion of breast
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05978648
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.