MedTrace Logo

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

NCT03412955 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-02-27

No results posted yet for this study

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

Interventions

DRUG

Eribulin Mesylate

1.4mg/m2/dose on days 1 and 8 of a 21-day treatment cycle.

Sponsors & Collaborators

  • Tan Tock Seng Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-08
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • Singapore
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03412955 on ClinicalTrials.gov