PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment

• Status: Completed
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

On March 17th, 2011, the European Commission issued a marketing authorization valid throughout the European Union for Eribulin mesylate (Halaven; Eisai Limited), for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapic regimens for advanced disease.

As the use of Eribulin will be widespread in this tumor setting, a better knowledge of its safety profile outside clinical trials is warranted.

Indeed the possibility to select patients at risk for developing Eribulin-induced neuropathy, will allow the exclusion from these treatment of those patients harbouring the specific single nucleotide polymorphism (SNP). Given that Eribulin toxicity often results in treatment discontinuation, the ability to anticipate which patients will experience severe toxicity could allow for either early intervention or even possibly for prophylactic therapy, or for selection of the patients to be treated.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oncologia Medica dell'Ospedale Fatebenefratelli
• Collaborator: Mario Negri Institute for Pharmacological Research

Criteria

Inclusion Criteria:

• Diagnosis of metastatic breast cancer

• Previous treatment with anthracyclines and taxanes

• Patients who will start Eribulin or who have already received only the first dose (cycle 1, day 1) of Eribulin according to the approved indication

• Ability to comply with sample collection

• Patient has signed the study Informed Consent Form (ICF) and the specific Pharmacogenetic ICF.

• Absence of any contraindication to treatment

Exclusion Criteria:

• Previous treatment with Eribulin in a previous line of treatment

• Previous treatment with Eribulin off label