PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment

PHASE4CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

December 31, 2018

Study Completion Date

December 31, 2020

Conditions
Metastatic Breast CancerToxicityNeurotoxicityDrug ToxicityAdverse Drug Event
Interventions
DRUG

ERIBULIN MESYLATE

"Eribulin mesylate will be administered according to the European Medicines Agency (EMA) and Italian Medicines Agency (AIFA) approved indications and schedule consists in 1.23 mg/m2 on day 1 and on day 8 of each cycle. Cycles will be repeated every 21 days until progression of disease, unacceptable toxicity, patient refusal or medical decision.~The decision to treat patients with Eribulin is independent from the trial. Patients will be treated and managed according to clinical practice. The physician can choose any further line of treatment after disease progression with Eribulin."

Trial Locations (20)

5100

A.O. Santa Maria di Terni, Terni

12100

Azienda Ospedaliera S. Croce e Carle, Cuneo

20025

Ospedale Civile di Legnano, Legnano

20121

Oncologia Medica Ospedale Fatebenefratelli, Milan

23100

Azienda Ospedaliera Valtellina e Valchiavenna - Presidio di Sondrio, Sondrio

24047

Ospedale di Treviglio, Treviglio

26100

Istituti Ospitalieri di Cremona, Cremona

27100

Fondazione IRCCS Policlinico San Matteo di Pavia, Pavia

29100

Azienda Ospedaliera di Piacenza, Piacenza

33100

Azienda Ospedaliero-Universitaria Santa Maria della Misericordia, Udine

39100

Comprensorio sanitario di Bolzano, Bolzano

50134

A.O.U. Careggi, Florence

73100

A.O. Vito Fazzi, Lecce

84016

ASL Salerno Presidio Ospedaliero Andrea Tortora, Pagani

00128

POliclinico Universitario Campus Bio-Medico, Roma

00133

Fondazione Policlinico Tor Vergata, Roma

00144

"Istituto Nazionale Tumori Regina Elena Oncologia Medica A", Roma

"Istituto Nazionale Tumori Regina Elena Oncologia medica B", Roma

00168

Policlinico Universitario Agostino Gemelli, Roma

03039

ASL di FRosinone Ospedale SS Trinità di Sora, Sora

All Listed Sponsors
collaborator

Mario Negri Institute for Pharmacological Research

OTHER

lead

Oncologia Medica dell'Ospedale Fatebenefratelli

OTHER_GOV

NCT02864030 - PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment | Biotech Hunter | Biotech Hunter