PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment

March 3, 2021 updated by: Oncologia Medica dell'Ospedale Fatebenefratelli

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is primarily aimed at surveying the tolerability profile of Eribulin in an unselected population of patients with metastatic breast cancer in relation to toxicities already described in clinical trials, and neurotoxicity in particular.

The secondary objectives of this trial include:

  • To study the relationship between specific genetic polymorphism and incidence and severity of peripheral neuropathy
  • To describe treatment efficacy in terms of duration of treatment and impact on survival.

All toxicities will be collected and classified according to National Cancer Institute Common Terminology criteria for Adverse Events (NCI CTCAE) version 4.0 and monitored during all the treatment period and up to 30 days after therapy discontinuation.

In particular, evaluation of incidence and outcome of any grade AEs already recorded in previous clinical trials will be collected, as follows:

  • asthenia/fatigue,
  • neutropenia,
  • alopecia,
  • nausea,
  • peripheral neuropathy
  • constipation

Any other unexpected AEs shall be evaluated likewise.

Patients must be followed for AEs until every ongoing Eribulin-related/unrelated toxicity and AE have been resolved, or the Investigator assesses them as "chronic" or "stable" or until the end of the trial, whichever comes first. For patients who will begin a new anticancer therapy after the last study drug administration, the AEs reporting period will end at the time the new treatment starts.

For the determination of polymorphisms, a routine blood collection of two tubes with 3-5 ml of blood be performed. The sample can be collected at any time during the participant's first two treatment cycles. Blood will be collected in a Vacutainer containing ethylendiaminetetraacetic acid (EDTA). Immediately after blood collection, tubes have to be inverted (at least five times) and then stored at - 20° C.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bolzano, Italy, 39100
        • Comprensorio Sanitario di Bolzano
      • Cremona, Italy, 26100
        • Istituti Ospitalieri di Cremona
      • Cuneo, Italy, 12100
        • Azienda Ospedaliera S. Croce e Carle
      • Firenze, Italy, 50134
        • A.O.U. Careggi
      • Lecce, Italy, 73100
        • A.O. Vito Fazzi
      • Legnano, Italy, 20025
        • Ospedale Civile di Legnano
      • Milano, Italy, 20121
        • Oncologia Medica Ospedale Fatebenefratelli
      • Pagani, Italy, 84016
        • ASL Salerno Presidio Ospedaliero Andrea Tortora
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo di Pavia
      • Piacenza, Italy, 29100
        • Azienda Ospedaliera di Piacenza
      • Roma, Italy, 00168
        • Policlinico Universitario Agostino Gemelli
      • Roma, Italy, 00128
        • Policlinico Universitario Campus Bio-Medico
      • Roma, Italy, 00133
        • Fondazione Policlinico Tor Vergata
      • Roma, Italy, 00144
        • Istituto Nazionale Tumori "Regina Elena" Oncologia Medica A
      • Roma, Italy, 00144
        • Istituto Nazionale Tumori "Regina Elena" Oncologia medica B
      • Sondrio, Italy, 23100
        • Azienda Ospedaliera Valtellina e Valchiavenna - Presidio di Sondrio
      • Sora, Italy, 03039
        • ASL di FRosinone Ospedale SS Trinità di Sora
      • Terni, Italy, 5100
        • A.O. Santa Maria di Terni
      • Treviglio, Italy, 24047
        • Ospedale di Treviglio
      • Udine, Italy, 33100
        • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single arm with Eribulin mesylate
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.

Other Names:
  • HALAVEN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence, time of onset, severity and duration of all Adverse Events (AEs) experienced during treatment with Eribulin (any grade)
Time Frame: Trough study completion, an average of 1 year
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
Time Frame: Trough study completion, an average of 1 year
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
Time Frame: Trough study completion, an average of 1 year
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)
Time Frame: Trough study completion, an average of 1 year
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)
Time Frame: Trough study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The European Organization for research and treatment of cancer Quality of Life Questionnaire EORTC QLQ - C30
Time Frame: Trough study completion, an average of 1 year
This is a kind of assessment to evaluate the quality of life of cancer patients during Eribulin treatment using unique measurements that share a common Unit of Measure
Trough study completion, an average of 1 year
Breast Cancer-Specific Quality of Life Questionnaire QlQ - BR23
Time Frame: Trough study completion, an average of 1 year
This is a kind of assessment to evaluate the quality of life during Eribulin treatment using unique measurements that share a common Unit of Measure
Trough study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oncologia Medica dell'Ospedale Fatebenefratelli

Collaborators

Mario Negri Institute for Pharmacological Research

Investigators

  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

August 3, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Actual)

March 4, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAINTER01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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