NCT05033769

Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer

AIRE - Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer - a Prospectively Randomized Phase IV Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Institut fuer Frauengesundheit · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

After progression of disease after one chemotherapy, metastatic breast cancer patients will be randomized 1:1 to one of the following treatment arms: Arm A. Eribulin Arm B. Paclitaxel Blood draws for immune analysis will be performed before start of therapy, on day 1 of cycle 2 and on day 21 of cycle 4 (end of therapy) for the primary study aim. Patients will be treated under study conditions for a maximum of 4 therapy cycles.

Detailed description

This is a prospective, randomized Phase IV study. Patients who progressed after one chemotherapy in the metastatic setting will be randomized 1:1 to one of the following treatment arms. Arm A. Eribulin 1.23 mg/m2 on days 1 and 8 q21d Arm B. Paclitaxel 80 mg/m2 on days 1, 8, and 15 q21d Blood draws for immune analysis will be performed before start of therapy on day 1 of cycle 1, on day 1 of cycle 2 (pre dose each) and on day 21 of cycle 4 (end of therapy) and assessed for the primary study aim. Patients will be treated under study conditions for a maximum of 4 therapy cycles.

Conditions

• Breast Cancer Female
• Neoplasm, Breast
• Breast Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Eribulin Injection [Halaven]	on days 1 and 8 q21d
DRUG	Paclitaxel injection	on days 1, 8, and 15 q21d

Timeline

• Start date: 2021-03-11
• Primary completion: 2023-07-01
• Completion: 2023-09-15
• First posted: 2021-09-05
• Last updated: 2023-04-18

Locations

2 sites across 1 country: Germany