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
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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer Toxicity Neurotoxicity Drug Toxicity Adverse Drug Event||Drug: ERIBULIN MESYLATE||Phase 4|
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:
- peripheral neuropathy
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official 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|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
|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 Name: HALAVEN
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864030
|Comprensorio sanitario di Bolzano|
|Bolzano, Italy, 39100|
|Istituti Ospitalieri di Cremona|
|Cremona, Italy, 26100|
|Azienda Ospedaliera S. Croce e Carle|
|Cuneo, Italy, 12100|
|Firenze, Italy, 50134|
|A.O. Vito Fazzi|
|Lecce, Italy, 73100|
|Ospedale Civile di Legnano|
|Legnano, Italy, 20025|
|Oncologia Medica Ospedale Fatebenefratelli|
|Milano, Italy, 20121|
|ASL Salerno Presidio Ospedaliero Andrea Tortora|
|Pagani, Italy, 84016|
|Fondazione IRCCS Policlinico San Matteo di Pavia|
|Pavia, Italy, 27100|
|Azienda Ospedaliera di Piacenza|
|Piacenza, Italy, 29100|
|POliclinico Universitario Campus Bio-Medico|
|Roma, Italy, 00128|
|Fondazione Policlinico Tor Vergata|
|Roma, Italy, 00133|
|Istituto Nazionale Tumori "Regina Elena" Oncologia Medica A|
|Roma, Italy, 00144|
|Istituto Nazionale Tumori "Regina Elena" Oncologia medica B|
|Roma, Italy, 00144|
|Policlinico Universitario Agostino Gemelli|
|Roma, Italy, 00168|
|Azienda Ospedaliera Valtellina e Valchiavenna - Presidio di Sondrio|
|Sondrio, Italy, 23100|
|ASL di FRosinone Ospedale SS Trinità di Sora|
|Sora, Italy, 03039|
|A.O. Santa Maria di Terni|
|Terni, Italy, 5100|
|Ospedale di Treviglio|
|Treviglio, Italy, 24047|
|Azienda Ospedaliero-Universitaria Santa Maria della Misericordia|
|Udine, Italy, 33100|
|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|