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PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02864030
Recruitment Status : Active, not recruiting
First Posted : August 11, 2016
Last Update Posted : August 23, 2018
Sponsor:
Collaborator:
Mario Negri Institute for Pharmacological Research
Information provided by (Responsible Party):
Oncologia Medica dell'Ospedale Fatebenefratelli

Tracking Information
First Submitted Date  ICMJE August 3, 2016
First Posted Date  ICMJE August 11, 2016
Last Update Posted Date August 23, 2018
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2016)
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
  • 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 CTCAE v4.0 criteria, especially the most common AEs reported in previous clinical studies (asthenia/fatigue, neutropoenia, alopecia, nausea, peripheral neuropathy and constipation) but also other possible unexpected toxicities.
  • 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.
  • 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.
  • DOT (Duration Of Treatment) [ Time Frame: Trrough 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).
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 12, 2016)
  • 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
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: August 10, 2016)
  • EORTC QLQ-C30 questionnaire [ 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 tratment using unique measurements that share a common Unit of Measure
  • 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 tratment using unique measurements that share a common Unit of Measure
 
Descriptive Information
Brief Title  ICMJE PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment
Official Title  ICMJE 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
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Metastatic Breast Cancer
  • Toxicity
  • Neurotoxicity
  • Drug Toxicity
  • Adverse Drug Event
Intervention  ICMJE 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 Name: HALAVEN
Study Arms  ICMJE Single arm with Eribulin mesylate
Intervention: Drug: ERIBULIN MESYLATE
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 10, 2016)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02864030
Other Study ID Numbers  ICMJE PAINTER01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Oncologia Medica dell'Ospedale Fatebenefratelli
Study Sponsor  ICMJE Oncologia Medica dell'Ospedale Fatebenefratelli
Collaborators  ICMJE Mario Negri Institute for Pharmacological Research
Investigators  ICMJE
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
PRS Account Oncologia Medica dell'Ospedale Fatebenefratelli
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP