NCT05206656

Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer

Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer Patients: An Open-Labeled, Single-center, Prospective Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Hunan Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Eribulin is the promising agent for late-line metastatic breast cancer patients. The aim of this Phase II, double-arm, open-label and prospective clinical trial is to assess the efficacy and safety of Eribullin or Eribulin combined with Anlotinib in patients with metastatic breast cancer

Detailed description

The aim of the double-arm, open-label, phase II clinical trial is to assess efficacy and safety of Eribulin or Eribulin combined with Anlotinib in metastatic breast cancers. The investigator hypothesize that both Eribulin and Eribulin combined with Anlotinib may be an effective alternative treatment for metastatic breast cancers. In addition, Eribulin combined with Anlotinib might be able to improve the treatment response and progression-free survival.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Eribulin Mesylate	Eribulin mesylate injection is performed on Day 1 and Day 8 of each treatment cycle (21 days per cycle). Patients were treated for six cycles, except disease progression (PD) or treatment stop for other reasons, such as severe adverse effects.
DRUG	Anlotinib	12 mg Anlotinib is administered for continuous 14 days in 21 day cycles. Patients received Anlotinib untill disease progression.

Timeline

• Start date: 2020-10-09
• Primary completion: 2022-04-30
• Completion: 2022-07-20
• First posted: 2022-01-25
• Last updated: 2022-11-23

Locations

1 site across 1 country: China