Locally Advanced or Metastatic Breast CancerIRENENCT03027245
Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy
An observational study of Locally Advanced or Metastatic Breast Cancer, run by Eisai GmbH at 65 sites in Germany.
Trial summary
Study E7389-M044-504 is an observational, post-authorization, single-arm, prospective, multicenter cohort study conducted to characterize and determine the incidence of eribulin-induced peripheral neuropathy (PN), and the frequency and time to resolution of eribulin-induced PN in adult participants treated with… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced or Metastatic Breast Cancer
- What is being tested?
- Eribulin
- How many people
- 353 participants
- Where
- 65 sitesGermany
- Study dates
- 13 Oct 2016to 31 May 2022
- Phase
- Observational
- 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
Study population: Female participants greater than or equal to (>=) 18 years with locally advanced or MBC
Who may be able to join
- Locally advanced or MBC with progression after at least one chemotherapeutic regimen for advanced disease eligible for treatment with eribulin according to Fachinformation. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless participants were not suitable for these treatments
- 1-3 prior chemotherapeutic regimens for advanced disease
- Age >=18 years at the time of Informed Consent
- Ability to understand and willingness to respond to questions related to their health
- Decision for the participant to start treatment with eribulin has been made prior to inclusion in this study.
- Signed written Informed Consent
Who cannot join
- Previous treatment with eribulin in any line of treatment
- Contraindication according to the Fachinformation of eribulin
- Pregnancy or lactation
- Participation in an interventional clinical trial at the same time
Trial locations and contacts
65 sites in 1 country.
65 sites in 1 country
Germany65 sites
Eisai Trial Site 1
Amberg
Eisai Trial Site 1
Aschaffenburg
Eisai Trial Site 2
Aschaffenburg
Eisai Trial Site 1
Augsburg
Eisai Trial Site 2
Augsburg
Eisai Trial Site 1
Aurich
Eisai Trial Site 1
Berlin
Eisai Trial Site 2
Berlin
Eisai Trial Site 3
Berlin
Eisai Trial Site 1
Bonn
Eisai Trial Site 2
Bonn
Eisai Trial Site 1
Cologne
Eisai Trial Site 2
Cologne
Eisai Trial Site 1
Darmstadt
Eisai Trial Site 1
Donauwörth
EISAI Trial Site 1
Dresden
Eisai Trial Site 1
Düren
Eisai Trial Site 1
Essen
Eisai Trial Site 1
Esslingen am Neckar
Eisai Trial Site 1
Eutin
Eisai Trial Site 1
Freiburg im Breisgau
Eisai Trial Site 1
Fürstenwalde
Eisai Trial Site 1
Gelsenkirchen
Eisai Trial Site 1
Georgsmarienhütte
Eisai Trial Site 1
Greifswald
Eisai Trial Site 1
Hanover
Eisai Trial Site 2
Hanover
Eisai Trial Site 1
Hof
Eisai Trial Site 1
Homburg
Eisai Trial Site 1
Ilsede
Eisai Trial Site 1
Karlsruhe
Eisai Trial Site 1
Kassel
Eisai Trial Site 1
Kiel
Eisai Trial Site 2
Kiel
Eisai Trial Site 1
Koblenz
Eisai Trial Site 1
Lahr
Eisai Trial Site 1
Landshut
Eisai Trial Site 1
Lemgo
Eisai Trial Site 1
Lübeck
Eisai Trial Site 1
Magdeburg
Eisai Trial Site 1
Mainz
Eisai Trial Site 1
Mannheim
Eisai Trial Site 1
Marktredwitz
Eisai Trial Site 1
München
Eisai Trial Site 2
München
Eisai Trial Site 3
München
Eisai Trial Site 1
Münster
Eisai Trial Site 1
Naunhof
Eisai Trial Site 1
Nuremberg
Eisai Trial Site 1
Oberhausen
Eisai Trial Site 1
Offenbach
Eisai Trial Site 1
Offenburg
Eisai Trial Site 1
Oldenburg
Eisai Trial Site 1
Potsdam
Eisai Trial Site 1
Püttlingen
Eisai Trial Site 1
Quedlinburg
Eisai Trial Site 1
Rodgau
Eisai Trial Site 1
Rotenburg (Wümme)
Eisai Trial Site 1
Saarlouis
Eisai Trial Site 1
Stolberg
Eisai Trial Site 1
Stuttgart
Eisai Trial Site 2
Stuttgart
Eisai Trial Site 1
Tübingen
Eisai Trial Site 1
Villingen-Schwenningen
Eisai Trial Site 1
Worms
About this study
Official title: Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy (IRENE)
Study E7389-M044-504 is an observational, post-authorization, single-arm, prospective, multicenter cohort study conducted to characterize and determine the incidence of eribulin-induced peripheral neuropathy (PN), and the frequency and time to resolution of eribulin-induced PN in adult participants treated with eribulin in a real-life setting with locally advanced or metastatic breast cancer (MBC) who have progressed following at least one and up to three chemotherapeutic regimens for advanced disease.
- Being tested
- Eribulin
- Keywords
- locally advanced or metastatic breast cancer, peripheral neuropathy, chemotherapy-induced peripheral neuropathy, eribulin
- Medical subject headings
- Breast Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EribulinDrug
| Study group | Role | What they receive |
|---|---|---|
| Eribulin-treated participants | Participants treated with eribulin according to Fachinformation and managed according to clinical practice Receives: Drug: Eribulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants experiencing eribulin-induced peripheral neuropathy (PN)
Measured: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Percentage of participants experiencing eribulin-induced PN
Measured: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Number of participants with the indicated grade of eribulin-induced PN, as determined by Common Terminology Criteria for Adverse Events (CTCAE), grade version 4.0
Measured: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Percentage of participants who experienced dose modifications of eribulin treatment due to eribulin-induced PN
Measured: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Percentage of participants who discontinued eribulin treatment due to eribulin-induced PN
Measured: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Time to eribulin treatment discontinuation due to eribulin-induced PN
Measured: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Number of resolved cases in participants who experience eribulin-induced PN
A resolved case is defined as one that ended or returned to baseline as determined by CTCAE grade version 4.0
Measured: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Percentage of resolved cases in participants who experience eribulin-induced PN
A resolved case is defined as one that ended or returned to baseline as determined by CTCAE grade version 4.0
Measured: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Time to resolution of eribulin-induced PN
Time to resolution is defined as the time from onset (or worsening from baseline) to the date of resolution (defined as stop of PN or return to baseline), as determined by CTCAE grade version 4.0.
Measured: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Number of therapeutic interventions (e.g., analgesics) being used to treat eribulin-induced PN
Measured: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Secondary outcomes (5)
Health-related quality of life scores measured using the Patient Neurotoxicity Questionnaire
Measured: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Health-related quality of life scores measured using the EuroQOl-5 Dimensions-3 Levels (EQ-5D-3L) questionnaire
Measured: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Time to disease progression
Time to disease progression is defined as the time from the start of eribulin treatment to Investigator assessment of disease progression (clinical or radiological)
Measured: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Number of participants with any serious adverse event (SAE) and number of participants with any non-serious AE
Measured: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Percentage of participants with any SAE and percentage of participants with any non-serious AE
Measured: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start13 Oct 2016
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Breast CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027245
- Sponsor's protocol ID
- E7389-M044-504
- Acronym
- IRENE
- Status last verified
- Mar 2022
- First submitted
- 19 Jan 2017
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy (IRENE)
- ClinicalTrials.gov ID
- NCT03027245
- Acronym / sponsor ID
- IRENE / E7389-M044-504
- Keywords
- locally advanced or metastatic breast cancer, peripheral neuropathy, chemotherapy-induced peripheral neuropathy, eribulin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Eisai GmbHIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2016 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 23 Jan 2017 (estimated)
- 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.
Study E7389-M044-504 is an observational, post-authorization, single-arm, prospective, multicenter cohort study conducted to characterize and determine the incidence of eribulin-induced peripheral neuropathy (PN), and the frequency and time to resolution of eribulin-induced PN in adult participants treated with eribulin in a real-life setting with locally advanced or metastatic breast cancer (MBC) who have progressed following at least one and up to three chemotherapeutic regimens for advanced disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eribulin-treated participants | – | Drug: EribulinParticipants treated with eribulin according to Fachinformation and managed according to clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female participants greater than or equal to (>=) 18 years with locally advanced or MBC
Key inclusion criteria (6 listed)
- Locally advanced or MBC with progression after at least one chemotherapeutic regimen for advanced disease eligible for treatment with eribulin according to Fachinformation. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless participants were not suitable for these treatments
- 1-3 prior chemotherapeutic regimens for advanced disease
- Age >=18 years at the time of Informed Consent
- Ability to understand and willingness to respond to questions related to their health
- Decision for the participant to start treatment with eribulin has been made prior to inclusion in this study.
Key exclusion criteria (4 listed)
- Previous treatment with eribulin in any line of treatment
- Contraindication according to the Fachinformation of eribulin
- Pregnancy or lactation
- Participation in an interventional clinical trial at the same time
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 | Drug | Eribulin-treated participants |
Primary outcome
Number of participants experiencing eribulin-induced peripheral neuropathy (PN)
Time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Percentage of participants experiencing eribulin-induced PN
Time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Number of participants with the indicated grade of eribulin-induced PN, as determined by Common Terminology Criteria for Adverse Events (CTCAE), grade version 4.0
Time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Percentage of participants who experienced dose modifications of eribulin treatment due to eribulin-induced PN
Time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Percentage of participants who discontinued eribulin treatment due to eribulin-induced PN
Time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Time to eribulin treatment discontinuation due to eribulin-induced PN
Time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Number of resolved cases in participants who experience eribulin-induced PN
Time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
A resolved case is defined as one that ended or returned to baseline as determined by CTCAE grade version 4.0
Percentage of resolved cases in participants who experience eribulin-induced PN
Time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
A resolved case is defined as one that ended or returned to baseline as determined by CTCAE grade version 4.0
Time to resolution of eribulin-induced PN
Time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Time to resolution is defined as the time from onset (or worsening from baseline) to the date of resolution (defined as stop of PN or return to baseline), as determined by CTCAE grade version 4.0.
Number of therapeutic interventions (e.g., analgesics) being used to treat eribulin-induced PN
Time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
5 secondary outcomes
Health-related quality of life scores measured using the Patient Neurotoxicity Questionnaire
Time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Health-related quality of life scores measured using the EuroQOl-5 Dimensions-3 Levels (EQ-5D-3L) questionnaire
Time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Time to disease progression
Time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Number of participants with any serious adverse event (SAE) and number of participants with any non-serious AE
Time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Percentage of participants with any SAE and percentage of participants with any non-serious AE
Time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
65 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced or Metastatic Breast Cancer, run by Eisai GmbH at 65 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants experiencing eribulin-induced peripheral neuropathy (PN) (time frame: Approximately 15 months, or until death or resolution of peripheral neuropathy, or return to baseline level, whichever comes first). The study lists 10 primary outcomes in all. 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 13 Jul 2022.