Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer
- Conditions
- Breast Cancer FemaleNeoplasm, BreastBreast Cancer Metastatic
- Interventions
- Registration Number
- NCT05033769
- Lead Sponsor
- Institut fuer Frauengesundheit
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 82
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paclitaxel Paclitaxel injection Paclitaxel 80 mg/m\^2, administered as an injection on day 1, 8 and 15 q21d for a maximum of 4 therapy cycles Eribulin Eribulin Injection [Halaven] 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
- Primary Outcome Measures
Name Time Method Immune responsivity (IR) 12 weeks after therapy start defined as ≥ 5% of all T cells from peripheral blood are Ki-67 positive after chemotherapy
- Secondary Outcome Measures
Name Time Method Progression free survival From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months Progression free survival
Overall survival From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months Overall survival
Toxicity and safety of eribulin and paclitaxel Therapy start until 30 days post last dose Toxicity and safety of eribulin and paclitaxel
EORTC QLQC30 Therapy start until therapy end after 4 cycles up to 12 weeks Quality of life assessed via EORTC QLQC30
Overall response after three months three months after therapy start Overall response
Trial Locations
- Locations (2)
Department of Gynecology, Tübingen University Hospital
🇩🇪Tübingen, Baden-Württemberg, Germany
Department of Gynecology and Obstetrics, Erlangen University Hospital
🇩🇪Erlangen, Bavaria, Germany