CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 52 enrolled
Drug / intervention
Pembrolizumab Injection +1 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/NCT03515798
NCT03515798Phase 2Active
CompareCT.gov

A Prospective Multicenter Open-label, Randomized Phase II Study of Pembrolizumab in Combination With Neoadjuvant EC-Paclitaxel Regimen in HER2-negative Inflammatory Breast Cancer.

Institut Paoli-Calmettes·interventional·Posted May 4, 2018·Updated Sep 12, 2025

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab Injection and neoadjuvant EC-paclitaxel chemotherapy for Inflammatory Breast Cancer. Active but no longer recruiting, targeting 52 participants across 12 sites.

Detailed Summary

This phase II multicentre randomized open-label study will assess the safety and efficacy of Pembrolizumab in combination with standard chemotherapy in inflammatory breast cancer. Pembrolizumab will be administered every 3 weeks during the neoadjuvant chemotherapy. Tissue and blood samples will be collected pre- and post-treatment for translational research.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInflammatory Breast Cancer
CountriesFrance
CollaboratorsMSD France, Oncodistinct

Timeline

Phase 2Active
201920202021202220232024202520262027
First PostedMay 4, 2018
Enrollment StartAug 29, 2018
Primary CompletionAug 22, 2022
Study CompletionAug 22, 2027
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 8.2 years ago

Interventions

Pembrolizumab Injectiondrug

Patients will receive intravenously 1 dose of Pembrolizumab every 3 weeks

neoadjuvant EC-paclitaxel chemotherapydrug

The cytotoxic regimen is a combination of dose-dense EC, followed by weekly paclitaxel