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Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negative Breast Cancer)

NCT07255612 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-12-01

No results posted yet for this study

Summary

Triple negative breast cancer (TNBC) has attracted much attention due to its young age of onset, high aggressiveness, lack of clear therapeutic targets and poor clinical prognosis.Eribulin is a novel non-taxane anti-microtubule inhibitor with unique microtubule and non-microtubule anti-tumor mechanism.Myelosuppression is the cause of many cancer chemotherapy-related adverse events, such as infections, sepsis, bleeding, and fatigue, resulting in delayed hospital stays or the need for treatment with hematopoietic growth factors, blood transfusions, and more.In addition, myelosuppression usually leads to a lower dose or longer interval of chemotherapy, which reduces the intensity of chemotherapy and affects the benefit of chemotherapy for patients.Trilaciclib is a highly potent, selective and reversible CDK4/6 inhibitor that protects bone marrow by protecting hematopoietic stem cells and progenitor cells (HSPCs) during systemic chemotherapy.

Conditions

Interventions

DRUG

Eribulin

Each participant receives Eribulin(1.4mg/m², intravenous infusion at day 1 and day 8, with 1 cycle at day 21)

DRUG

Trilaciclib

Each participant receives Trilaciclib(240mg/m², intravenous infusion for 30 minutes, and completed within 4 hours before chemotherapy administration on day 1 and day 8, day 21 was 1 cycle)

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-04
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07255612 on ClinicalTrials.gov