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AIRE - Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer - a Prospectively Randomized Phase IV Study
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.
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Department of Gynecology, Tübingen University Hospital
Tübingen, Baden-Wurttemberg, Germany
Department of Gynecology and Obstetrics, Erlangen University Hospital
Erlangen, Bavaria, Germany
Start Date
March 11, 2021
Primary Completion Date
July 1, 2023
Completion Date
September 15, 2023
Last Updated
April 18, 2023
82
ESTIMATED participants
Eribulin Injection [Halaven]
DRUG
Paclitaxel injection
DRUG
Lead Sponsor
Institut fuer Frauengesundheit
Collaborators
NCT06878248
NCT06715826
Data Source & Attribution
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