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

Sponsor
Sun Yat-sen University
Study ID
NCT07255612
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Dec 1, 2025
Start date
Nov 4, 2026
Status verified
Nov 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
29 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Trilaciclib Plus Eribulin
    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; Eribulin: 1.4mg/m², intravenous infusion at day 1 and day 8, with 1 cycle at day 21; Note: Trilaciclib combined with Eribulin was treated for cycles 1-2, and continued use of trilaciclib combined with eribulin was a clinical decision from cycle 3 onwards.The infusion interval between treacilil and subsequent injections should not exceed 4 hours. Hematopoietic growth factor, blood transfusion, or platelet transfusion are not allowed during the week prior to the blood test during the subject screening period, and no prophylaxis of any cytogenic subclass drugs (including granulocyte colony stimulating factor, granulocyte giant cell colony co-stimulating factor, and erythropoietin) is allowed during the first cycle.However, it can be used therapeutically and should be used in strict accordance with relevant guidelines.

Primary Outcome Measure

Prevalence of grade 3 neutropenia during cycle 1-2 of chemotherapy treatment [ Time Frame: 6 months ]

Central Contacts

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