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NCT07255612

PHASE2

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-11-04

Completion Date

2026-12-01

Last Updated

2025-12-01

Healthy Volunteers

Conditions

Breast Cancer

Interventions

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)

Inclusion Criteria: 1. ≥18 years old , no limitation of gender; 2. locally advanced or metastatic triple-negative breast cancer; 3. have received at least two prior chemotherapy regimens(The recurrence of the last adjuvant chemotherapy is counted one line within 12 months after surgery); 4. At least one measurable lesion according to RECIST version 1.1; 5. The laboratory tests meet the following criteria: Hemoglobin: ≥ 100 g / L (female), 110g / L (male) Neutrophil count : ≥2×10\^9/L Platelet count: ≥100×10\^9/L Creatinine：≤15mg / L or creatinine clearance (CrCl) ≥60 mL/min (Cockcroft-Gault formula); Total bilirubin：≤1.5× upper limit of normal (ULN) Alutamate aminotransferase (ALT) and glutamate aminotransferase (AST)≤ 3 ×ULN or 5 ×ULN (for patients with liver metastases) Albumin: ≥ 30 g / L; 6. Eastern Cooperative Oncology Group (ECOG) score \[0-1\] points; 7. The expected survival period is ≥3 months; 8. During the screening period, all female with potential fertility must have negative serum pregnancy tests and reliable contraception after signing the informed consent form until 3 months after the last dose; 9. Comprehend and voluntarily sign the informed consent form; Exclusion Criteria: 1. Diagnosed other malignant disease besides breast cancerwithin 5 years before the first dose (excluding radical skin basal cell carcinoma, skin squamous epithelial carcinoma, and / or radical resection); 2. Main organ function not good enough; 3. Bone marrow invasion; 4. Require combined chemotherapy other than Eribulin; 5. Stroke or cardiovascular and cerebrovascular events within 6 months before enrollment; 6. QTcF \> 480 msec ( screening period) and QTcF\> 500 msec for patients with ventricular pacemaker implantation; 7. Previous hematopoietic stem cell or bone marrow transplantation; 8. Previous G-CSF treatment in the last 2 weeks; 9. Allergic to the study drug or the ingredients; 10. Any other situation where the researcher considers the patient not suitable to participate in this study.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China