NCT06678230

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

Multicenter, Single-Arm, Phase II Clinical Trial of Eribulin in Combination with Anrotinib for HER-2 Negative Locally Advanced or Metastatic Breast Cancer.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Detailed description

This is a single-arm, single-center, Phase II clinical trial of eribulin in combination with amlotinib in subjects with HER-2 negative locally advanced or metastatic breast cancer. The trial is planned to enroll 40 subjects with HER-2 negative locally advanced or metastatic breast cancer who have received prior chemotherapy with anthracycline and paclitaxel-based agents to receive eribulin in combination with erlotinib. Trial drug: eribulin 1.4 mg/m2, D1,8; one cycle every 3 weeks; Amlotinib 12 mg, QD, po, applied for 14 days and stopped for 7 days, one cycle every 3 weeks. All subjects will receive long-term dosing until intolerable toxicity or disease progression or death or voluntary withdrawal or the end of this trial (meaning completion of the trial or early termination of the trial). During the treatment period, all subjects will be evaluated for antitumor efficacy every 6 weeks and disease status will be determined by the investigator according to RECIST 1.1 criteria until disease progression or death or refusal to come to the hospital for follow-up or the end of the trial (meaning completion of the trial or early termination of the trial), whichever event occurs first. After a subject\'s disease progression or refusal to come to the hospital for follow-up, the investigator will make a telephone visit every 3 months (each month will be counted as 30 days) to obtain information about the subject\'s survival, whether he/she is receiving other antitumor therapy, etc.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-10-01
• Completion: 2025-10-20
• First posted: 2024-11-07
• Last updated: 2024-11-07

Locations

1 site across 1 country: China