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

NCT07255612 | Not Yet Recruiting Phase 2

• 1 other identifier: PROTECTION
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Prevalence of grade 3 neutropenia during cycle 1-2 of chemotherapy treatment

  evaluated by CIM related index(Chemotherapy-Induced Myelosuppression) , CTCAE5.0(Common Terminology Criteria for Adverse Events)

  6 months

Secondary Outcomes (7)

• Anti-tumor efficacy

  6 months

• Adverse events, abnormal laboratory tests, etal

  6 months

• Bone marrow protection

  6 months

• Disease burden(cost)

  6 months

• Disease burden(in-stay time)

  6 months

Study Arms (1)

Trilaciclib Plus Eribulin

EXPERIMENTAL

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.

Drug: Trilaciclib; Drug: Eribulin

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)

Trilaciclib Plus Eribulin

Eribulin DRUG

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

Trilaciclib Plus Eribulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old , no limitation of gender;
• locally advanced or metastatic triple-negative breast cancer;
• have received at least two prior chemotherapy regimens(The recurrence of the last adjuvant chemotherapy is counted one line within 12 months after surgery);
• At least one measurable lesion according to RECIST version 1.1;
• 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;
• Eastern Cooperative Oncology Group (ECOG) score \[0-1\] points;
• The expected survival period is ≥3 months;
• 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;
• Comprehend and voluntarily sign the informed consent form;

You may not qualify if:

• 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);
• Main organ function not good enough;
• Bone marrow invasion;
• Require combined chemotherapy other than Eribulin;
• Stroke or cardiovascular and cerebrovascular events within 6 months before enrollment;
• QTcF \> 480 msec ( screening period) and QTcF\> 500 msec for patients with ventricular pacemaker implantation;
• Previous hematopoietic stem cell or bone marrow transplantation;
• Previous G-CSF treatment in the last 2 weeks;
• Allergic to the study drug or the ingredients;
• Any other situation where the researcher considers the patient not suitable to participate in this study.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

trilaciclib; eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Fei Xu, MD

CONTACT

13711277870; xufei@sysucc.org.cn

Kuikui Jiang, MD

CONTACT

15210589011; jiangkk@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: December 1, 2025
• Study Start (Estimated): November 4, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)