NCT03412955

A Pilot Study of Eribulin in Breast Cancer (BC) Patients With Brain Metastases Previously Treated With Anthracyclines and Taxanes

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Tan Tock Seng Hospital · Academic / Other
• Sex: Female
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study, the principal investigator plans to enroll 14 patients. If 2 or more responses are documented, the principal investigator will consider to start a new phase II study. If there is less than 2 responses in the 14 patients, it is unlikely that Eribulin will produce 15% or more response rate in patients with active brain metastases, thus indicating no need to study further. Based on Poisson distribution, there is 38% probability of observing 1 or 0 response even if the underlying response is 15%. There is no null hypothesis, hence no p-value of significance.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Eribulin Mesylate	1.4mg/m2/dose on days 1 and 8 of a 21-day treatment cycle.

Timeline

• Start date: 2017-03-08
• Primary completion: 2020-04-30
• Completion: 2020-04-30
• First posted: 2018-01-29
• Last updated: 2018-02-27

Locations

2 sites across 2 countries: Singapore, Taiwan