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

Breast Cancer Female Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05033769
Study type Interventional
Source Institut fuer Frauengesundheit
Contact AIRE Study manager
Phone +49 (0) 9131 927 9578
Email aire@ifg-erlangen.de
Status Recruiting
Phase Phase 4
Start date March 11, 2021
Completion date September 15, 2023
View Details
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