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

NCT05033769 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2023-04-18

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Eribulin Injection [Halaven]

on days 1 and 8 q21d

DRUG

Paclitaxel injection

on days 1, 8, and 15 q21d

Sponsors & Collaborators

  • Eisai GmbH

    collaborator INDUSTRY

  • Institut fuer Frauengesundheit

    lead OTHER

Principal Investigators

  • Peter A Fasching, MD, Prof. · Department of Gynecology and Obstetrics, Erlangen University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-11
Primary Completion
2023-07-01
Completion
2023-09-15

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05033769 on ClinicalTrials.gov