Breast Cancer FemalePhase 4AIRENCT05033769
Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer
A Phase 4 study testing Eribulin Injection [Halaven] and Paclitaxel injection in people with Breast Cancer Female and Neoplasm, Breast, run by Institut fuer Frauengesundheit at 2 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Neoplasm, Breast, Breast Cancer Metastatic
- What is being tested?
- Eribulin Injection [Halaven] and Paclitaxel injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesGermany
- Study dates
- 11 Mar 2021to 15 Sep 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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).
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Department of Gynecology and Obstetrics, Erlangen University Hospital
Erlangen, Bavaria, 91054
Peter A Fasching, Prof. Dr., +49 9131 85 ext. 43470, peter.fasching@uk-erlangen.de
- Recruiting
Department of Gynecology, Tübingen University Hospital
Tübingen, Baden-Wurttemberg, 72076
Andreas Hartkopf, MD, Prof., +49 07071 29 82211, andreas.hartkopf@med.uni-tuebingen.de
About this study
Official title: AIRE - Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer - a Prospectively Randomized Phase IV Study
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.
Read the 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.
- Being tested
- Eribulin Injection [Halaven], Paclitaxel injection
- Keywords
- Immunoresponse
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eribulin Injection [Halaven]Drug
Also called Eribulin
on days 1 and 8 q21d
Paclitaxel injectionDrug
Also called Paclitaxel
on days 1, 8, and 15 q21d
| Study group | Role | What they receive |
|---|---|---|
| Eribulin | Experimental | 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 Receives: Drug: Eribulin Injection [Halaven] |
| Paclitaxel | Active comparator | Paclitaxel 80 mg/m^2, administered as an injection on day 1, 8 and 15 q21d for a maximum of 4 therapy cycles Receives: Drug: Paclitaxel injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune responsivity (IR)
defined as ≥ 5% of all T cells from peripheral blood are Ki-67 positive after chemotherapy
Measured: 12 weeks after therapy start
Secondary outcomes (5)
Overall response after three months
Overall response
Measured: three months after therapy start
Progression free survival
Progression free survival
Measured: 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
Overall survival
Overall survival
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months
Toxicity and safety of eribulin and paclitaxel
Toxicity and safety of eribulin and paclitaxel
Measured: Therapy start until 30 days post last dose
EORTC QLQC30
Quality of life assessed via EORTC QLQC30
Measured: Therapy start until therapy end after 4 cycles up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start11 Mar 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion15 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut fuer Frauengesundheit
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai GmbH
- Responsible party
- Sponsor
- Investigators
- Peter A Fasching, MD, Prof., Study chair, Department of Gynecology and Obstetrics, Erlangen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033769
- Sponsor's protocol ID
- IFG-06-2019
- Other IDs
- 2020-001938-35, AGO-B-049
- Acronym
- AIRE
- Status last verified
- Jun 2022
- First submitted
- 19 Jun 2020
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIRE - Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer - a Prospectively Randomized Phase IV Study
- ClinicalTrials.gov ID
- NCT05033769
- Acronym / sponsor ID
- AIRE / IFG-06-2019
- Keywords
- Immunoresponse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Institut fuer FrauengesundheitUniversity, hospital or other
- Collaborators
- Eisai GmbH
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eribulin | Experimental | Drug: 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 |
| Paclitaxel | Active comparator | Drug: Paclitaxel injectionPaclitaxel 80 mg/m^2, administered as an injection on day 1, 8 and 15 q21d for a maximum of 4 therapy cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eribulin Injection [Halaven]Also: Eribulinon days 1 and 8 q21d | Drug | Eribulin |
| Paclitaxel injectionAlso: Paclitaxelon days 1, 8, and 15 q21d | Drug | Paclitaxel |
Primary outcome
Immune responsivity (IR)
Time frame: 12 weeks after therapy start
defined as ≥ 5% of all T cells from peripheral blood are Ki-67 positive after chemotherapy
5 secondary outcomes
Overall response after three months
Time frame: three months after therapy start
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
Overall survival
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months
Toxicity and safety of eribulin and paclitaxel
Time frame: Therapy start until 30 days post last dose
EORTC QLQC30
Time frame: Therapy start until therapy end after 4 cycles up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer Female
Recruiting
Decision Support for Chemoprevention
Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter A Fasching, MD, Prof. study chair
Department of Gynecology and Obstetrics, Erlangen University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eribulin Injection [Halaven] and Paclitaxel injection in people with Breast Cancer Female and Neoplasm, Breast, run by Institut fuer Frauengesundheit at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AIRE Study manager (+49 (0) 9131 927 9578, aire@ifg-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune responsivity (IR) (time frame: 12 weeks after therapy start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.