CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 90 enrolled
Drug / intervention
Eribulin Mesylate +1 moredrug
Likely dose
Eribulin mesylate (dose not specified in INTERVENTIONS or ARMS); Pembrolizumab (dose not specified)AI-extracted
Key inclusion· 7
  • Stage IV invasive breast cancer with unequivocal evidence of metastasis
  • HR-positive, HER2-negative breast cancer (ER >1% and/or PR >1%)
  • At least two prior lines of hormonal therapy OR appropriate candidate for chemotherapy
  • Up to 2 prior lines of metastatic chemotherapy allowed
Key exclusion· 8
  • Prior treatment with eribulin mesylate or any anti-PD-1/PD-L1/PD-L2 agent
  • Unresolved chemotherapy or radiation-related toxicities >Grade 1 (except stable neuropathy ≤Grade 2 and alopecia)
  • Known untreated, symptomatic, or uncontrolled brain metastases
  • Uncontrolled intercurrent illness (hypertension, cardiac arrhythmia, heart failure NYHA III-IV, MI within 6 months, uncontrolled diabetes)

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

Search/NCT03051659
NCT03051659Phase 2Completed

A Randomized Phase II Study Of Eribulin Mesylate With Or Without Pembrolizumab For Metastatic Hormone Receptor Positive Breast Cancer

Dana-Farber Cancer Institute·interventional·Posted Feb 14, 2017·Updated Mar 6, 2024

In Brief

A Phase 2 clinical trial evaluating Eribulin Mesylate and Pembrolizumab for Breast Cancer. Completed, enrolled 90 participants across 3 sites.

Detailed Summary

This research study is exploring chemotherapy in combination with immunotherapy (a therapy that uses the body's own immune system to control cancer) as a possible treatment for metastatic hormone receptor positive breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 14, 2017
Enrollment StartMar 22, 2017
Primary CompletionOct 11, 2018
Study CompletionSep 5, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.4 years ago

Interventions

Eribulin Mesylatedrug

Eribulin mesylate is developed from a natural substance found in a sea sponge. Eribulin mesylate works by preventing cancer cells from multiplying

Pembrolizumabdrug

Pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells.