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Clinical Trial of Eribulin in Combination with Anrotinib for HER-2 Negative Locally Advanced or Metastatic Breast Cancer

NCT06678230 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-11-07

No results posted yet for this study

Summary

Study Objective: To evaluate the progression-free survival of HER-2 negative locally advanced or metastatic breast cancer subjects treated with eribulin in combination with erlotinib Trial Drug: Erlotinib Targets: Erlotinib is a novel small-molecule multi-targeted tyrosine kinase inhibitor, which can inhibit the kinase activities of vascular endothelial growth factor receptor (VEGFR1-3), platelet-derived growth factor receptor (PDGFRα, PDGFRβ), fibroblast growth factor receptor (FGFR1-4), stem cell growth factor receptor, etc., and thus exert anti-tumor angiogenesis, thereby exerting anti-tumor angiogenesis and anti-vascularity. PDGFRα, PDGFRβ), fibroblast growth factor receptor (FGFR1-4), stem cell growth factor receptor and other kinase activities, and then play the role of anti-tumor angiogenesis and inhibition of tumor growth. Results of previous studies, known efficacy and adverse effects: The single-agent regimen of amlotinib has been clinically approved in non-small cell lung cancer, gastric cancer, and soft tissue sarcoma. In breast cancer, the II clinical study of amlotinib monotherapy for the treatment of HER-2 negative advanced breast cancer in the second line and above showed that the PFS of amlotinib monotherapy was 5.22 months, ORR was 15.4%, and DCR was 80.8%, which demonstrated that amlotinib has better anti-tumor activity. Major adverse reactions: fatigue, weight loss, hypertension, diarrhea, nausea, vomiting, hematemesis

Conditions

Interventions

DRUG

Anlotinib

Alibulin 1.4mg/m2, D1, 8; Every 3 weeks is a cycle; Androtinib 12mg, QD, po, applied for 14 days, stopped for 7 days, and every 3 weeks was a cycle.

Sponsors & Collaborators

  • The First Hospital of Jilin University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2025-10-01
Completion
2025-10-20

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT06678230 on ClinicalTrials.gov