PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment

NCT02864030 | Completed Phase 4

• 1 other identifier: PAINTER01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Metastatic Breast Cancer; Toxicity; Neurotoxicity; Drug Toxicity; Adverse Drug Event

Keywords

Eribulin mesylate; Halaven; Polymorphisms; Tolerability

Outcome Measures

Primary Outcomes (5)

• Incidence, time of onset, severity and duration of all Adverse Events (AEs) experienced during treatment with Eribulin (any grade)

  All toxicities and their grade will be reported according to Common Terminology criteria for Adverse Events (CTCAE) v4.0, especially the most common AEs reported in previous clinical studies (asthenia/fatigue, neutropenia, alopecia, nausea, peripheral neuropathy and constipation) but also other possible unexpected toxicities.

  Trough study completion, an average of 1 year

• Association between a set of selected polymorphisms and the onset of any grade peripheral neuropathy

  The association between a set of selected polymorphisms and the onset of all grades peripheral neuropathy will be investigated using blood samples collected at the time of treatment initiation.

  Trough study completion, an average of 1 year

• Treatment tolerability

  Treatment tolerability will also be described in terms of dose intensity and dose schedule maintenance.

  Trough study completion, an average of 1 year

• DOT (Duration Of Treatment)

  DOT will be calculated for each patient from the date of start of Eribulin treatment to the date of last Eribulin administration for any cause (i.e. progression of disease, unacceptable toxicity, patient refusal or physician decision).

  Trough study completion, an average of 1 year

• OS (Overall Survival)

  OS will be calculated from the date of start of therapy to the date of death.

  Trough study completion, an average of 1 year

Other Outcomes (2)

• The European Organization for research and treatment of cancer Quality of Life Questionnaire EORTC QLQ - C30

  Trough study completion, an average of 1 year

• Breast Cancer-Specific Quality of Life Questionnaire QlQ - BR23

  Trough study completion, an average of 1 year

Study Arms (1)

Single arm with Eribulin mesylate

OTHER

Drug: ERIBULIN MESYLATE

Interventions

ERIBULIN MESYLATE DRUG

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.

Also known as: HALAVEN

Single arm with Eribulin mesylate

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous treatment with Eribulin in a previous line of treatment
• Previous treatment with Eribulin off label

Sponsors & Collaborators

• Oncologia Medica dell'Ospedale Fatebenefratelli: lead
• Mario Negri Institute for Pharmacological Research: collaborator

Study Sites (20)

Comprensorio sanitario di Bolzano

Bolzano, 39100, Italy

Location

Istituti Ospitalieri di Cremona

Cremona, 26100, Italy

Location

Azienda Ospedaliera S. Croce e Carle

Cuneo, 12100, Italy

Location

A.O.U. Careggi

Florence, 50134, Italy

Location

A.O. Vito Fazzi

Lecce, 73100, Italy

Location

Ospedale Civile di Legnano

Legnano, 20025, Italy

Location

Oncologia Medica Ospedale Fatebenefratelli

Milan, 20121, Italy

Location

ASL Salerno Presidio Ospedaliero Andrea Tortora

Pagani, 84016, Italy

Location

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, 27100, Italy

Location

Azienda Ospedaliera di Piacenza

Piacenza, 29100, Italy

Location

POliclinico Universitario Campus Bio-Medico

Roma, 00128, Italy

Location

Fondazione Policlinico Tor Vergata

Roma, 00133, Italy

Location

Istituto Nazionale Tumori "Regina Elena" Oncologia Medica A

Roma, 00144, Italy

Location

Istituto Nazionale Tumori "Regina Elena" Oncologia medica B

Roma, 00144, Italy

Location

Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

Location

Azienda Ospedaliera Valtellina e Valchiavenna - Presidio di Sondrio

Sondrio, 23100, Italy

Location

ASL di FRosinone Ospedale SS Trinità di Sora

Sora, 03039, Italy

Location

A.O. Santa Maria di Terni

Terni, 5100, Italy

Location

Ospedale di Treviglio

Treviglio, 24047, Italy

Location

Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

Udine, 33100, Italy

Location

Related Publications (22)

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• La Verde N, Damia G, Garrone O, Santini D, Fabi A, Ciccarese M, Generali DG, Nunzi M, Poletto E, Ferraris E, Cretella E, Scandurra G, Meattini I, Bertolini AS, Cavanna L, Collova E, Romagnoli E, Rulli E, Legramandi L, Guffanti F, Bramati A, Moretti A, Cassano A, Vici P, Torri V, Farina G; PAINTER investigators. Tolerability of Eribulin and correlation between polymorphisms and neuropathy in an unselected population of female patients with metastatic breast cancer: results of the multicenter, single arm, phase IV PAINTER study. Breast Cancer Res. 2022 Oct 28;24(1):71. doi: 10.1186/s13058-022-01560-w.

  PMID: 36307826 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Neurotoxicity Syndromes; Drug-Related Side Effects and Adverse Reactions

Interventions

eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Laboratory of Clinical Research Department of Oncology IRCCS

  Istituto Di Ricerche Farmacologiche Mario Negri

  STUDY CHAIR

• Giovanna Damia, PHD

  Istituto Di Ricerche Farmacologiche Mario Negri

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 11, 2016
• Study Start: May 1, 2014
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2020
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (20)