CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 27 enrolled
Drug / intervention
everolimus +3 moredrug
Likely dose
Not stated in 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/NCT02120469
NCT02120469Phase 1Completed
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Phase I/IB Trial of Eribulin and Everolimus in Patients With Triple Negative Metastatic Breast Cancer

City of Hope Medical Center·interventional·Posted Apr 22, 2014·Updated Jul 5, 2022

In Brief

A Phase 1 clinical trial evaluating everolimus, eribulin mesylate, and 2 other interventions for Estrogen Receptor Negative and 4 related conditions. Completed, enrolled 27 participants across 3 sites.

Detailed Summary

This phase I/IB trial studies the side effects and best dose of eribulin mesylate and everolimus in treating patients with breast cancer that does not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 protein (triple-negative) and has spread to other places in the body (metastatic). Eribulin mesylate and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEstrogen Receptor Negative, HER2/Neu Negative, Progesterone Receptor-negative, Stage IV Breast Cancer, Triple-negative Breast Carcinoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 22, 2014
Enrollment StartOct 1, 2014
Primary CompletionMar 20, 2019
Study CompletionMar 3, 2020
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 12.2 years ago

Interventions

everolimusdrug

Given PO

eribulin mesylatedrug

Given IV

pharmacological studyother

Correlative studies

laboratory biomarker analysisother

Optional correlative studies