NCT04796324

Anti-tumor Effect of Ixabepilone in Metastatic Breast Cancer (mBC) Selected by the Ixabepilone DRP.

Phase II, Open Label, Single Arm Study to Investigate Anti-tumor Effect of Ixabepilone in Patients With Locally Recurrent or Metastatic Breast Cancer (mBC) Selected by the Ixabepilone DRP After Failure of an Anthracycline and Taxanes.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Allarity Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose is to investigate anti-tumor effect of ixabepilone in patients with locally recurrent or metastatic breast cancer (mBC) selected by the Ixabepilone DRP after failure of an anthracycline and taxanes.

Detailed description

Patients will be screened with the Ixabepilone DRP. If the tumor tissue has a DRP( Drug Response Prediction) score of \>67% (Belgium \>33%) the patient can be included in the clinical study. Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Ixabepilone Injection	Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle

Timeline

• Start date: 2021-03-01
• Primary completion: 2024-12-01
• Completion: 2025-11-01
• First posted: 2021-03-12
• Last updated: 2026-03-12
• Results posted: 2026-03-12

Locations

19 sites across 7 countries: Belgium, Finland, Germany, Italy, Netherlands, Poland, United Kingdom

Regulatory

• FDA-regulated drug study