Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Arm A. Eribulin 1.23 mg/m\^2, administered as an injection on day 1 and 8 q 21d for a maximum of 4 therapy cycles

Paclitaxel 80 mg/m\^2, administered as an injection on day 1, 8 and 15 q21d for a maximum of 4 therapy cycles

Eribulin Injection [Halaven]

Paclitaxel injection

AIRE Study manager

Andreas Hartkopf, MD, Prof.

Peter A Fasching, Prof. Dr.

Peter A Fasching, MD, Prof.

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.

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

defined as ≥ 5% of all T cells from peripheral blood are Ki-67 positive after chemotherapy

Toxicity and safety of eribulin and paclitaxel

Quality of life assessed via EORTC QLQC30

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer	NCT05033769	Breast Cancer F... Neoplasm, Breas... Breast Cancer M...	Eribulin Inject... Paclitaxel inje...	18 Years -	Institut fuer Frauengesundheit
Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer	NCT05033769	Breast Cancer F... Neoplasm, Breas... Breast Cancer M...	Eribulin Inject... Paclitaxel inje...	18 Years -	Institut fuer Frauengesundheit
Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer	NCT05033769	Breast Cancer F... Neoplasm, Breas... Breast Cancer M...	Eribulin Inject... Paclitaxel inje...	18 Years -	Institut fuer Frauengesundheit

Spots Global Cancer Trial Database for immunoresponse