Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Breast Cancer Metastatic | — | UNRESOLVED | — |
| Neoplasm, Breast | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eribulin Injection [Halaven] | Drug | Eribulin | ALIAS |
| Paclitaxel injection | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Eribulin
- description
- 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
- interventionNames
- Drug: Eribulin Injection [Halaven]
- type
- ACTIVE_COMPARATOR
- label
- Paclitaxel
- description
- Paclitaxel 80 mg/m\^2, administered as an injection on day 1, 8 and 15 q21d for a maximum of 4 therapy cycles
- interventionNames
- Drug: Paclitaxel injection
Primary outcomes (1)
- measure
- Immune responsivity (IR)
- timeFrame
- 12 weeks after therapy start
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent prior to beginning of trial specific procedures * Subject must be female and aged ≥ 18 years on day of signing informed consent * ECOG 0-1 * Histologically confirmed, HER2 negative breast cancer determined by core biopsy of tumor lesion. Human epidermal growth factor receptor 2 (HER2) negativity is defined as either of the following by local laboratory assessment: In situ hybridization (ISH) non-amplified (ratio ≤ 2.2), or IHC 0 or IHC 1+. * Indication for chemotherapy * Previous therapy with one chemotherapy line * Target lesion (RECIST 1.1) * Adequate organ function defined as: Creatinine Clearance \> 50 ml/min ANC ≥ 1.5 x 10 3 /μL Thrombocytes \> 100 x 10 3 /μL Exclusion Criteria: * HER2 positive disease * Indication for an anti-hormone treatment * Active infection requiring systemic therapy. * Active autoimmune disease or other diseases that requires systemic treatment with corticosteroids or immunosuppressive drugs. * History of primary or acquired immunodeficiency (including allogenic organ transplant). * Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis). * Severely impaired liver function (Child Pugh C) * Hypersensitivity to study medication or any of its components * Neuropathy (PNP) \> Grade 2 (CTCAE 5.0) * Congenital long QT syndrome * Preexisting concomitant use of strong CYP3A4 and CYP2C8 inhibiting or inducing drugs * Life expectancy of less than three months * Pregnancy (contraception is required according tocontraceptive guidance) * Lactation * Known history of following infections: Human immunodeficiency virus (HIV), History of acute or chronic Hepatitis B or Hepatitis C * Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted. * Does not agree to blood collection
References
Publications (0)
Data not yet available