CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 258 enrolled
Drug / intervention
Eribulin Mesylate +1 moredrug
Likely dose
Eribulin Mesylate 1.4 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02513472
NCT02513472Phase 2Completed
CompareCT.gov

An Open-Label, Single-Arm Multicenter Phase 1b/2 Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Combination With Pembrolizumab in Subjects With Metastatic Triple-Negative Breast Cancer (mTNBC)

Eisai Inc.·interventional·Posted Jul 31, 2015·Updated May 5, 2022

In Brief

A Phase 2 clinical trial evaluating Eribulin Mesylate and Pembrolizumab for Breast Neoplasm. Completed, enrolled 258 participants across 22 sites.

Detailed Summary

This is an open-label, single-arm, multicenter, Phase 1b/2 study of eribulin mesylate in combination with pembrolizumab in participants with mTNBC previously treated with 0 (stratum 1) or 1 to 2 (stratum 2) lines of systemic anticancer therapy (cytotoxic or targeted anticancer agents) in the metastatic setting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasm
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 31, 2015
Enrollment StartAug 28, 2015
Primary CompletionJul 31, 2019
Study CompletionApr 6, 2021
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 10.9 years ago

Interventions

Eribulin Mesylatedrug

Eribulin Mesylate will be administered as a 1.4 milligram per square meter (mg/m\^2) IV (intravenous) infusion on Day 1 and Day 8 of each 21-day cycle in the presence of clinical benefit until intercurrent illness, unacceptable toxicity, or disease progression occurs, or until the participant withdraws consent.

Pembrolizumabdrug

Pembrolizumab will be administered as a 200 milligram (mg) IV infusion on Day 1 of each 21-day cycle in the presence of clinical benefit until intercurrent illness, unacceptable toxicity, or disease progression occurs, or until the participant withdraws consent.