Skip to main content
OpenTrials
Completed

NCT Number: NCT02864030

PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Breast Cancer Adverse Drug Event Breast Diseases Breast Neoplasms Chemically-Induced Disorders Drug Toxicity Drug-Related Side Effects and Adverse Reactions Neoplasms Neoplasms by Site Nervous System Diseases Neurotoxicity Neurotoxicity Syndromes Poisoning Skin Diseases Skin and Connective Tissue Diseases Toxicity

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Comprensorio sanitario di Bolzano, Bolzano, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: HALAVEN

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

Other outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Oncologia Medica dell'Ospedale Fatebenefratelli

Other Gov

Collaborators

  • Mario Negri Institute for Pharmacological Research

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2020
First posted
Aug 11, 2016
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.