NCT07520760

A Multicenter, Single-Arm, Phase II Exploratory Study of Eribulin in Combination With Anlotinib for HER2-Negative Recurrent/Metastatic Breast Cancer Previously Treated With Antibody-Drug Conjugates

A Multicenter, Single-Arm, Phase II Exploratory Study of Eribulin in Combination With Anlotinib for HER2-Negative Recurrent/Metastatic Breast Cancer Previously Treated With Antibody-Drug Conjugates（MBC-EA-II-01）

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is looking at a new combination of two drugs-eribulin and anlotinib-for patients with HER2-negative advanced breast cancer. Participants in this study have already tried other treatments like T-DXd or SG, but their cancer has gotten worse, and there are currently no standard treatment options left for them. Researchers believe that using these two drugs together may work better than using either one alone based on how they target cancer cells. The goal is to offer a new choice and help improve survival for these patients.

Detailed description

This is an exploratory study designed to evaluate the efficacy of eribulin in combination with anlotinib in patients with HER2-negative recurrent or metastatic breast cancer who have experienced treatment failure with antibody-drug conjugates (ADCs). The study aims to assess the efficacy and safety of eribulin combined with anlotinib in the treatment of patients with recurrent or metastatic HER2-low breast cancer, and to provide clinical evidence supporting this novel combination regimen.

Conditions

• HER 2 Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Eribulin in Combination with Anlotinib	Participants will receive eribulin mesylate administered as a 1-hour intravenous infusion at a dose of 1.4 mg/m² on Days 1 and 8 of each 21-day cycle. Anlotinib will be administered orally at a dose of 8 mg once daily on Days 1 through 14 of each 21-day cycle, followed by a 7-day rest period. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of consent.

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-04-30
• Completion: 2035-04-30
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: China