Eribulin Use for the Treatment of Advanced Breast Cancer: A Prospective Observational Registry

Breast Cancer Clinical Trial

Official title:

Eribulin (HALAVEN) Use for the Treatment of Advanced Breast Cancer: A Prospective Observational Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443428
• Other study ID #: OBU-N-H-01
• Status: Completed
• Phase: N/A
• First received: May 11, 2015
• Last updated: April 14, 2016
• Start date: August 2013
• Est. completion date: October 2015

Study information

• Verified date: April 2016
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial Summary

The purpose of this prospective observational registry is to monitor safety of eribulin in routine clinical practice. Additionally, this study will also assess the effectiveness of eribulin in real-life settings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

The participants have to meet all of the following criteria to be eligible to enter into the prospective registry:

1. Participants older than 18 years of age

2. Willing and able to provide informed consent

3. Diagnosis of locally advanced or metastatic breast cancer

4. Progression after up to two previous chemotherapy regimens for advanced disease. Prior therapy should have included an anthracycline and a taxanes in either the adjuvant or advanced setting unless not suitable

5. Adequate bone marrow, liver, and renal function

6. Life expectancy greater than 12 weeks

Exclusion Criteria

Participants meeting the following criteria will not be permitted to enter the study:

1. Prior treatment with eribulin

2. Participants who have received more than two prior chemotherapeutic regimens for advanced disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Limited

Countries where clinical trial is conducted

Denmark,  Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs) and serious adverse events (SAEs)	Safety assessment will consist of monitoring of all AEs, including SAEs at every visit. All participants will be evaluable for safety from the time of their first treatment with eribulin.	From date of first administration of study drug up to 30 days after last administration of study drug or until approximately 2 years	Yes
Secondary	Tumour response		From date of enrollment, Day 1 and Day 8 of every 21 day cycle or up to approximately 2 years	No
Secondary	Overall survival (OS)		From date of first administration of study drug to date of death or up to approximately 2 years	No
Secondary	Demographic and clinical characteristics		Up to approximately 2 years	No
Secondary	Duration of treatment		Historical data collected at Baseline	No
Secondary	Incidence of dose delays		From date of first administration up to approximately 2 years	No
Secondary	Incidence of dose reductions		From date of first administration up to approximately 2 years	No
Secondary	Relative dose intensity (RDI) of eribulin		From date of first administration up to approximately 2 years	No
Secondary	Treatment patterns for locally advanced or metastatic breast cancer		Historical data collected at Baseline	No