Eribulin as a Second-line Treatment in Triple-negative Advanced Breast Cancer
NCT ID: NCT05302778
Last Updated: 2023-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2021-03-22
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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EISAI s.r.l.
UNKNOWN
University of Milano Bicocca
OTHER
Responsible Party
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Locations
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ASST Monza
Monza, , Italy
Oncologia Medica Policlinico Universitario Palermo
Palermo, , Italy
OSPEDALE LA MADDALENA, Palermo
Palermo, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HERMIONE-10
Identifier Type: -
Identifier Source: org_study_id
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