Trilaciclib in Patients With Early-Stage HR-negative Breast Cancer Receiving Adjuvant Chemotherapy

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(T

Trial Details

NCT ID

NCT05978648

Phase

PHASE2

Sponsor

wang shusen

Status

RECRUITING

Cancer Type

HER2 Negative Breast Cancer

Interventions

Trilaciclib
Epirubicin
Cyclophosphamide
Paclitaxel
Docetaxel
Carboplatin

Locations (sample)

Guangzhou, Gangdong, China|23.11667,113.25

Key Eligibility Criteria

age ≥ 18 years;
breast cancer meets the following criteria:
Histologically or cytologically confirmed and adequately resected non-metastatic primary invasive breast cancer;
Cohort A only: ER, PR negative (\< 1% nuclear staining as assessed by immunohistochemistry \[IHC\]), HER2 negative (HER2/CEP17 ratio \< 2.0 or mean…

For full eligibility, visit ClinicalTrials.gov.

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