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

Eisai

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02443428

OBU-N-H-01

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

77 participants in 1 patient group

Eribulin Mesilate

Description:

Participants will be treated in accordance with normal clinical practice. The recommend dose of eribulin is 1.23 mg/m2 administered intravenously on days 1 and 8 of every 21-day cycle. Treatment with eribulin is continued until disease progression, onset of unacceptable drug toxicities, or participant/physician's request to discontinue.