NCT04624711

Eribulin Combined With Anlotinib in Metastatic HER2 Negative Breast Cancer

A Multicenter, Phase II, Open-label, Single-arm Investigator Initiated Trial to Evaluate the Efficacy and Safety of Eribulin Mesylate Combined With Anlotinib in Metastatic HER2 Negative Breast Cancer Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, phase II, open-label, single-arm investigator initiated trial to evaluate the efficacy and safety of eribulin mesylate combined with anlotinib in metastatic HER2 negative breast cancer patients.

Detailed description

Breast cancer is the most frequent malignancy in women worldwide. Treatments on metastatic HER2 negative breast cancer are still under exploration. Therefore, it is imperative to find a novel therapy to treat these patients. This study explores the efficacy and safety of eribulin mesylate combined with anlotinib in metastatic HER2 negative breast cancer patients. The primary objective is to evaluate the progression free survival (PFS). The secondary objective is to evaluate the safety of the combination of eribulin and anlotinib.

Conditions

• HER2-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Eribulin Mesylate	Eribulin mesylate 1.4mg/m2, administered intravenously on Days 1 and 8 of each 21 day cycle.
DRUG	Anlotinib hydrochloride	Anlotinib 12mg, administered orally on Days 1-14 of each 21 day cycle.

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-06-01
• Completion: 2022-12-01
• First posted: 2020-11-12
• Last updated: 2021-05-21

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study