Breast CancerHERMIONE-10NCT05302778
Eribulin as a Second-line Treatment in Triple-negative Advanced Breast Cancer
An observational study of Breast Cancer and Metastatic Breast Cancer, run by University of Milano Bicocca at 3 sites in Italy.
Trial summary
Multicenter, retrospective and prospective, cohort, observational study evaluating the clinical efficacy and tolerability of Eribulin as second-line treatment in accordance with the indications authorized by AIFA in patients with triple negative advanced breast cancer in a real world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer
- How many people
- 200 participants
- Where
- 3 sitesItaly
- Study dates
- 22 Mar 2021to Dec 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic triple negative breast cancer
Who may be able to join
- Performance status according to ECOG equal to 0-2
- Locally advanced or triple negative metastatic breast cancer (HR- and HER2-) confirmed histologically
- Progressing after first-line chemotherapy for advanced disease
- Previous anthracyclines and taxanes therapy (in an adjuvant, neoadjuvant or metastatic), unless the patient is ineligible to receive such treatments
- Treatment with Eribulin mesylate since 2017, in accordance with AIFA indications
- Adequate haematological, renal and hepatic function, as per clinical practice
- Written informed consent
Who cannot join
- Breast cancer HER2 + or HR +
- Treatment with Eribulin in the context of clinical studies
- Patients unsuitable for treatment with Eribulin
- Diagnosis of other malignancies in the two years prior to enrollment, with one exception of adequately treated localized basal cell or squamous cell carcinomas of the skin o cervical carcinomas undergoing curative treatment
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Recruiting
ASST Monza
Monza
Marina E. Cazzaniga, MD, marina.cazzaniga@asst-monza.it
- Not yet recruiting
Oncologia Medica Policlinico Universitario Palermo
Palermo
Maria Rosaria Valerio, 0916552761, valerionc17@gmail.com
- Not yet recruiting
OSPEDALE LA MADDALENA, Palermo
Palermo
Gebbia Vittorio, vittorio.gebbia@gmail.com
About this study
Official title: Observational Study Evaluating the Role of Eribulin as a Second-line Treatment in Triple-negative Advanced Breast Cancer
Multicenter, retrospective and prospective, cohort, observational study evaluating the clinical efficacy and tolerability of Eribulin as second-line treatment in accordance with the indications authorized by AIFA in patients with triple negative advanced breast cancer in a real world setting.
Read the detailed description
The study, multicenter, retrospective and prospective, cohort, observational, describes the modalities of treatment with Eribulin as a second line therapy for triple negative breast cancer and "clinical outcomes" in a population real-world, evaluating any differences with the results obtained in clinical trials. Therapeutic sequences will also be evaluated with the aim of providing a photograph of the choices made in clinical practice in this historical moment characterized by rapid evolution of new molecules available to clinicians.
A total of at least 200 patients with triple negative advanced breast cancer treated with Eribulin as second line will be enrolled in the retrospective or prospective cohort. Enrollment period will last 2 years.
Pseudoanonymized data will be collected in a electroctronic database (RedCap Cloud); here the list of the main variables collected:
- Patient Registration
- Demography
- Pregnancy test
- Past history and habits of the patient
- Previous antineoplastic therapy
- Anamnesis close to entering the study
- Vital signs and ECOG performance status (WHO)
- Blood chemistry tests
- RECIST 1.1 Baseline and re-evaluations
- 12 Lead ECG evaluation
- Eribulin cycles
- Adverse events
- Previous and concomitant medications
- End of study
The retrospective analysis of the choices made in clinical practice and the benefits obtained from the second therapeutic lines could provide important data to favor the definition of prospective randomized studies, and guide the clinician towards a better therapeutic path.
- Keywords
- breast cancer, triple negative, second line, eribulin, real world
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS defined as time from the beginning of treatment to disease progression or death
Measured: Entire study duration, approximately 3 years
Secondary outcomes (7)
Time to progression (TTP)
TTP defined as the time from the beginning of treatment to disease progression or death
Measured: Entire study duration, approximately 3 years
Overall Response Rate (ORR)
OOR defined as the percentage of patients who achieved a partial response (PR) or a complete response (CR) as best response according to RECIST 1.1
Measured: Entire study duration, approximately 3 years
Disease Control Rate (DCR)
DCR defined as the percentage of patients who achieved a partial response (PR), a complete response (CR) or a stable disease (SD) as best response according to RECIST 1.1 criteria, according to the site of metastatic disease (bone disease vs visceral disease with or without bone involvement).
Measured: Entire study duration, approximately 3 years
Site of progression
Description of sites of progression in patients with first bone relapse
Measured: Entire study duration, approximately 3 years
Duration of response and disease control
Duration of response and disease control
Measured: Entire study duration, approximately 3 years
Survival after progression
Survival after progression
Measured: Entire study duration, approximately 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Entire study duration, approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start22 Mar 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Collaborators
- EISAI s.r.l.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302778
- Sponsor's protocol ID
- HERMIONE-10
- Acronym
- HERMIONE-10
- Status last verified
- May 2023
- First submitted
- 15 Mar 2022
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Evaluating the Role of Eribulin as a Second-line Treatment in Triple-negative Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT05302778
- Acronym / sponsor ID
- HERMIONE-10 / HERMIONE-10
- Keywords
- breast cancer, triple negative, second line, eribulin, real world
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Collaborators
- EISAI s.r.l.
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 31 Mar 2022 (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.
Multicenter, retrospective and prospective, cohort, observational study evaluating the clinical efficacy and tolerability of Eribulin as second-line treatment in accordance with the indications authorized by AIFA in patients with triple negative advanced breast cancer in a real world setting.
Detailed description
The study, multicenter, retrospective and prospective, cohort, observational, describes the modalities of treatment with Eribulin as a second line therapy for triple negative breast cancer and "clinical outcomes" in a population real-world, evaluating any differences with the results obtained in clinical trials. Therapeutic sequences will also be evaluated with the aim of providing a photograph of the choices made in clinical practice in this historical moment characterized by rapid evolution of new molecules available to clinicians.
A total of at least 200 patients with triple negative advanced breast cancer treated with Eribulin as second line will be enrolled in the retrospective or prospective cohort. Enrollment period will last 2 years.
Pseudoanonymized data will be collected in a electroctronic database (RedCap Cloud); here the list of the main variables collected:
- Patient Registration
- Demography
- Pregnancy test
- Past history and habits of the patient
- Previous antineoplastic therapy
- Anamnesis close to entering the study
- Vital signs and ECOG performance status (WHO)
- Blood chemistry tests
- RECIST 1.1 Baseline and re-evaluations
- 12 Lead ECG evaluation
- Eribulin cycles
- Adverse events
- Previous and concomitant medications
- End of study
The retrospective analysis of the choices made in clinical practice and the benefits obtained from the second therapeutic lines could provide important data to favor the definition of prospective randomized studies, and guide the clinician towards a better therapeutic path.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic triple negative breast cancer
Key inclusion criteria (7 listed)
- Performance status according to ECOG equal to 0-2
- Locally advanced or triple negative metastatic breast cancer (HR- and HER2-) confirmed histologically
- Progressing after first-line chemotherapy for advanced disease
- Previous anthracyclines and taxanes therapy (in an adjuvant, neoadjuvant or metastatic), unless the patient is ineligible to receive such treatments
- Treatment with Eribulin mesylate since 2017, in accordance with AIFA indications
Key exclusion criteria (4 listed)
- Breast cancer HER2 + or HR +
- Treatment with Eribulin in the context of clinical studies
- Patients unsuitable for treatment with Eribulin
- Diagnosis of other malignancies in the two years prior to enrollment, with one exception of adequately treated localized basal cell or squamous cell carcinomas of the skin o cervical carcinomas undergoing curative treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival (PFS)
Time frame: Entire study duration, approximately 3 years
PFS defined as time from the beginning of treatment to disease progression or death
7 secondary outcomes
Time to progression (TTP)
Time frame: Entire study duration, approximately 3 years
Overall Response Rate (ORR)
Time frame: Entire study duration, approximately 3 years
Disease Control Rate (DCR)
Time frame: Entire study duration, approximately 3 years
Site of progression
Time frame: Entire study duration, approximately 3 years
Duration of response and disease control
Time frame: Entire study duration, approximately 3 years
Survival after progression
Time frame: Entire study duration, approximately 3 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Entire study duration, approximately 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Metastatic Breast Cancer, run by University of Milano Bicocca at 3 sites in Italy.
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 7 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: status not confirmed, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina E. Cazzaniga, MD (+39/0392339037, marina.cazzaniga@asst-monza.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Entire study duration, approximately 3 years). 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 25 May 2023.