Clinical trial NCT02443428: Eribulin Use for the Treatment of Advanced Breast Cancer: A Prospective Observational Registry
Official title: Eribulin (HALAVEN) Use for the Treatment of Advanced Breast Cancer: A Prospective Observational Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-13
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with locally advanced or metastatic breast cancer who have progressed after up to two chemotherapeutic regimens for advanced disease will be prospectively included in the registry. Prior therapy should have included an anthracycline and a taxanes unless the patient was not suitable for these treatments.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
timeFrame: From date of first administration of study drug up to 30 days after last administration of study drug or until approximately 2 years
Secondary outcomes:
measure: Tumour response
timeFrame: From date of enrollment, Day 1 and Day 8 of every 21 day cycle or up to approximately 2 years
measure: Overall survival (OS)
timeFrame: From date of first administration of study drug to date of death or up to approximately 2 years
measure: Demographic and clinical characteristics
timeFrame: Up to approximately 2 years
measure: Duration of treatment
timeFrame: Historical data collected at Baseline
measure: Incidence of dose delays
timeFrame: From date of first administration up to approximately 2 years
measure: Incidence of dose reductions
timeFrame: From date of first administration up to approximately 2 years
measure: Relative dose intensity (RDI) of eribulin
timeFrame: From date of first administration up to approximately 2 years
measure: Treatment patterns for locally advanced or metastatic breast cancer
timeFrame: Historical data collected at Baseline
Other outcomes:
Locations:
city: Aarhus
country: Denmark
city: Copenhagen
country: Denmark
city: Dublin
country: Ireland
city: Bath
country: United Kingdom
city: Cottingham
country: United Kingdom
city: Derby
country: United Kingdom
city: London
country: United Kingdom
city: Maidstone
country: United Kingdom
city: Manchester
country: United Kingdom
city: Norwich
country: United Kingdom
city: Oxford
country: United Kingdom
city: Plymouth
country: United Kingdom
Study officials:
affiliation: Guy's Hospital, Great Maze Pond
name: Hartmut Kristeleit
role: STUDY_DIRECTOR
References: