Back to resultsAssessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer (AIRE)
Primary Purpose
Breast Cancer Female, Neoplasm, Breast, Breast Cancer Metastatic
Status
Recruiting
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Eribulin Injection [Halaven]
Paclitaxel injection
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Female focused on measuring Immunoresponse
Eligibility Criteria
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
Sites / Locations
- Department of Gynecology, Tübingen University HospitalRecruiting
- Department of Gynecology and Obstetrics, Erlangen University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Eribulin
Paclitaxel
Arm 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
Paclitaxel 80 mg/m^2, administered as an injection on day 1, 8 and 15 q21d for a maximum of 4 therapy cycles
Outcomes
Primary Outcome Measures
Immune responsivity (IR)
defined as ≥ 5% of all T cells from peripheral blood are Ki-67 positive after chemotherapy
Secondary Outcome Measures
Overall response after three months
Overall response
Progression free survival
Progression free survival
Overall survival
Overall survival
Toxicity and safety of eribulin and paclitaxel
Toxicity and safety of eribulin and paclitaxel
EORTC QLQC30
Quality of life assessed via EORTC QLQC30
Full Information
NCT ID
NCT05033769
First Posted
June 19, 2020
Last Updated
April 14, 2023
Sponsor
Institut fuer Frauengesundheit
Collaborators
Eisai GmbH
1. Study Identification
Unique Protocol Identification Number
NCT05033769
Brief Title
Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer
Acronym
AIRE
Official Title
AIRE - Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer - a Prospectively Randomized Phase IV Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut fuer Frauengesundheit
Collaborators
Eisai GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female, Neoplasm, Breast, Breast Cancer Metastatic
Keywords
Immunoresponse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eribulin
Arm Type
Experimental
Arm 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
Arm Title
Paclitaxel
Arm Type
Active Comparator
Arm Description
Paclitaxel 80 mg/m^2, administered as an injection on day 1, 8 and 15 q21d for a maximum of 4 therapy cycles
Intervention Type
Drug
Intervention Name(s)
Eribulin Injection [Halaven]
Other Intervention Name(s)
Eribulin
Intervention Description
on days 1 and 8 q21d
Intervention Type
Drug
Intervention Name(s)
Paclitaxel injection
Other Intervention Name(s)
Paclitaxel
Intervention Description
on days 1, 8, and 15 q21d
Primary Outcome Measure Information:
Title
Immune responsivity (IR)
Description
defined as ≥ 5% of all T cells from peripheral blood are Ki-67 positive after chemotherapy
Time Frame
12 weeks after therapy start
Secondary Outcome Measure Information:
Title
Overall response after three months
Description
Overall response
Time Frame
three months after therapy start
Title
Progression free survival
Description
Progression free survival
Time Frame
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
Title
Overall survival
Description
Overall survival
Time Frame
From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months
Title
Toxicity and safety of eribulin and paclitaxel
Description
Toxicity and safety of eribulin and paclitaxel
Time Frame
Therapy start until 30 days post last dose
Title
EORTC QLQC30
Description
Quality of life assessed via EORTC QLQC30
Time Frame
Therapy start until therapy end after 4 cycles up to 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AIRE Study manager
Phone
+49 (0) 9131 927 9578
Email
aire@ifg-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A Fasching, MD, Prof.
Organizational Affiliation
Department of Gynecology and Obstetrics, Erlangen University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Gynecology, Tübingen University Hospital
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Hartkopf, MD, Prof.
Phone
+49 07071 29 82211
Email
andreas.hartkopf@med.uni-tuebingen.de
Facility Name
Department of Gynecology and Obstetrics, Erlangen University Hospital
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter A Fasching, Prof. Dr.
Phone
+49 9131 85
Ext
43470
Email
peter.fasching@uk-erlangen.de
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer
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