Status:
UNKNOWN
Eribulin as a Second-line Treatment in Triple-negative Advanced Breast Cancer
Lead Sponsor:
University of Milano Bicocca
Collaborating Sponsors:
EISAI s.r.l.
Conditions:
Breast Cancer
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Brief 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 author...
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 "clinic...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05302778
Start Date
March 22 2021
End Date
December 1 2023
Last Update
May 25 2023
Active Locations (3)
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1
ASST Monza
Monza, Italy
2
Oncologia Medica Policlinico Universitario Palermo
Palermo, Italy
3
OSPEDALE LA MADDALENA, Palermo
Palermo, Italy