Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants who are prescribed with Halaven per approved prescribing information of Halaven.

This is a PMS to observe the safety profile of Halaven in normal clinical practice setting.

Halaven Post-Marketing Surveillance (PMS)

Post-Marketing Surveillance of Halaven Injection in Korean Patients

Eisai Korea Inc.

Patients received 1.4 mg/m2 eribulin, administered intravenously on day 1 and 8 of each 21 day cycle until disease progression or unmanageable toxicity, per routine clinical practice.

The purpose of this study was to evaluate the efficacy and safety of eribulin in standard clinical practice in patients with locally recurrent or metastatic advanced breast cancer.

This was an observational, cross-sectional, retrospective, multicenter study conducted in Spain. During the year after authorization of the drug by the European Medicines Agency (EMA), patients in the compassionate use program (public sites) and patients treated in private sites (no purchase restrictions) who received at least 1 dose of treatment with eribulin per approved label at any of the 17 Spanish sites with the highest numbers of treated cases during that period (minimum 3 patients/site) were enrolled in this observational study. Approximately 112 patients will be enrolled in the study.

Eribulin [Halaven] Use For the Treatment of Advanced Breast Cancer

Eribulin [Halaven] Use For the Treatment of Advanced Breast Cancer: Observational Retrospective Analysis

Eisai Farmacêutica S.A.

Substance Related Disorders

Nervous System Diseases

Rare Diseases

Drug-Related Side Effects and Adverse Reactions

Neurotoxicity Syndromes

Chemically-Induced Disorders

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.

ERIBULIN MESYLATE

Laboratory of Clinical Research Department of Oncology IRCCS

Giovanna Damia, PHD

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.

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.

PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment

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

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

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

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.

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

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

Mario Negri Institute for Pharmacological Research

Oncologia Medica dell'Ospedale Fatebenefratelli

Symptoms and General Pathology

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Antiemetics

Dermatologic Agents

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Anti-Infective Agents

Ondansetron

Dexamethasone

Dexamethasone acetate

BB 1101

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate

Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.

Eribulin Mesylate

An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate

Zofran at 8mg orally. Given at the discretion of the treating physician

Pre-Medication: Zofran

decadron at 8mg orally. Given at the discretion of the treating physician

Pre-Medication: Decadron

Paula Silverman, MD

Subjects are asked to take part in a clinical research study that tests Eribulin, a new drug. Eribulin is an investigational (experimental) anti-cancer agent that has not been approved by the Food and Drug Administration (FDA) for use in patients with brain metastases. Eribulin is FDA approved for use in patients with metastatic breast cancer but the effect it may or may not have on brain metastases has not been studied.

Primary Objectives:

To determine the 3-month central nervous system (CNS)-progression free survival (PFS) for patients with metastatic breast cancer with brain metastases treated with eribulin mesylate.

Secondary Objective(s):

1. Estimate CNS complete and partial response rates (CR and PR) and duration of CNS response in this patient population.

2 Evaluate toxicity in patients with breast cancer with brain metastases treated with eribulin mesylate.

3 Estimate clinical benefit rate (CBR) at 3 months in breast cancer patients with brain metastases treated with eribulin mesylate. (CBR is the sum of CR, PR and stable disease at 3 months).

4 To estimate systemic disease (extra cranial) response rate and duration of systemic response in this patient population.

5 Overall survival in this patient population.

Design:

This is a phase II study that will require patients to evaluate the primary objective (CNS PFS at 3 months). Study patients will have a baseline brain MRI and a second MRI at 12 weeks to evaluate disease.

Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate

The study team will assess the percent of participants without CNS progression at 3 months. The study team will generate a Kaplan- Meier curve of CNS PFS and estimate the PFS and 95% confidence interval (CI) of the PFS. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.

The study team will calculate the percent of participants with complete and partial response. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.

The study team will calculate the duration of CNS response. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.

The study team will evaluate rates (and 95% CI) of toxicity in patients treated with eribulin.

The study team will sum the proportion of the patients with complete response, partial response and stable disease at 12 weeks (CBR)

The study team will estimate systemic disease response rate (and 95% CI) and perform a Kaplan-Meier analysis for systemic response in this patient population

The study team will generate a Kaplan-Meier curve of OS.

Case Comprehensive Cancer Center

The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate

Eribulin Mesylate: Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.

MRI: An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate

Pre-Medication: Zofran: Zofran at 8mg orally. Given at the discretion of the treating physician

Pre-Medication: Decadron: decadron at 8mg orally. Given at the discretion of the treating physician

years

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Paula Silverman

Percent of Participants With Central Nervous System (CNS) Progression Free Survival (PFS)

Objective Response Rate (RR)

Median Duration of CNS Response

Number of Patients Treated With Eribulin Who Experienced Serious Adverse Events

Number of Patients With CBR

Data not collected due to too few participants on study for a significant length of time

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Halaven Post-Marketing Surveillance (PMS)	NCT02441764	Breast Cancer		-	Eisai Inc.
Eribulin [Halaven] Use For the Treatment of Advanced Breast Cancer	NCT02790320	Metastatic Brea...		18 Years -	Eisai Inc.
PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment	NCT02864030	Metastatic Brea... Toxicity Neurotoxicity Drug Toxicity Adverse Drug Ev...	ERIBULIN MESYLA...	18 Years -	Oncologia Medica dell'Ospedale Fatebenefratelli
Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate	NCT02581839	Metastatic Brea... Brain Metastase...	Eribulin Mesyla... MRI Pre-Medication:... Pre-Medication:...	18 Years -	Case Comprehensive Cancer Center
Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate	NCT02581839	Metastatic Brea... Brain Metastase...	Eribulin Mesyla... MRI Pre-Medication:... Pre-Medication:...	18 Years -	Case Comprehensive Cancer Center
Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate	NCT02581839	Metastatic Brea... Brain Metastase...	Eribulin Mesyla... MRI Pre-Medication:... Pre-Medication:...	18 Years -	Case Comprehensive Cancer Center

Spots Global Cancer Trial Database for halaven

Every month we try and update this database with for halaven cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for halaven

Every month we try and update this database with for halaven cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for halaven cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.