NCT07255612

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

A Single-arm, Phase II Study for Bone Marrow Protection, Safety, and Efficacy of Trilaciclib Combined With Eribulin in Locally Advanced or Metastatic Triple-negative Breast Cancer After at Least Two Prior Chemotherapy Regimens

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Four randomized, double-blind clinical trials of treacilil in patients with small cell lung cancer (SCLC) confirmed that Trilaciclib administration in combination with chemotherapy prevented or mitigated chemotherapy-induced myelosuppression.Among them, the G1T28-05 study showed that the administration of Trilaciclib before first-line chemotherapy (carboplatin combined with etoposide) could reduce the duration of severe neutropenia in the first cycle from 4 days to 0 days, and the incidence of severe neutropenia from 49.1% to 1.9%.As the world's first drug designed to reduce chemotherapy-induced myelosuppression by protecting HSPCs, Trilaciclib has demonstrated a significant ability to prevent chemotherapy-mediated multicellular lineage myelosuppression in patients with ES-SCLC.In February 2021, the U.S. Food and Drug Administration (FDA) approved Trilaciclib (COSELA™) to reduce the incidence of chemotherapy-induced myelodepression in adult patients with extensive stage small cell lung cancer prior to receiving a platinum-containing/etoposide regimen or topotecan regimen. Based on the evidence that Trilaciclib has been approved by the FDA to reduce the incidence of chemotherapy-induced myelopathic depression in adult patients with extensive stage small cell lung cancer prior to receipt of a platinum-containing/etoposide regimen or topotecan regimen, there is encouraging patient outcome improvement observed in study G1T28-04.This Phase II clinical trial was designed to confirm the bone marrow protection and efficacy and safety of Trilaciclib in patients with locally advanced/metastatic TNBC who had previously received at least two chemotherapy regimes prior to treatment with Eribulin.

Conditions

• Breast Cancer

Interventions

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

Timeline

• Start date: 2026-11-04
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-12-01
• Last updated: 2025-12-01

Locations

1 site across 1 country: China