Multicenter, interventional, single-arm, phase IV study evaluating tolerability of Eribulin and its relationship with a set of polymorphisms in an unselected population of female patients with metastatic breast cancer - PAINTER: Polymorphism And INcidence of Toxicity in ERibulin treatment

Azienda Ospedaliera Fatebenefratelli e Oftalmico - Milano, Italy0 个研究点开始时间: 2013年12月9日最近更新: 2014年3月17日

适应症

试验速览

暂无简介。

•Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:
•1.Female patients =18 years
•2.Diagnosis of metastatic breast cancer
•3.Previous treatment with anthracyclines and taxanes
•4.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
•5.Ability to comply with sample collection
•6.Patient has signed the study Informed Consent Form (ICF) and the specific Pharmacogenetic ICF.
•7.Absence of any contraindication to treatment as in sections Contraindication” Special warning” and Interaction with other medicinal product” of the Summary of product characteristics (SPC).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 200
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•The presence of any of the following will exclude a subject from study enrollment:
•1.Previous treatment with Eribulin in a previous line of treatment
•2.Previous treatment with Eribulin off label

发起方

Azienda Ospedaliera Fatebenefratelli e Oftalmico - Milano, Italy