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

Breast Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03412955
Study type Interventional
Source Tan Tock Seng Hospital
Contact Elaine Tabanguil
Phone +6568802216
Email Elaine_E_TABANGUIL@ttsh.com.sg
Status Recruiting
Phase Phase 2
Start date March 8, 2017
Completion date April 30, 2020
View Details
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