MedTrace Logo

Study of Immunotherapy in Combination With Chemotherapy in HER2-negative Inflammatory Breast Cancer

NCT03515798 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-09-12

No results posted yet for this study

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.

Conditions

  • Inflammatory Breast Cancer

Interventions

DRUG

Pembrolizumab Injection

Patients will receive intravenously 1 dose of Pembrolizumab every 3 weeks

DRUG

neoadjuvant EC-paclitaxel chemotherapy

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

Sponsors & Collaborators

  • MSD France

    collaborator INDUSTRY

  • Oncodistinct

    collaborator UNKNOWN

  • Institut Paoli-Calmettes

    lead OTHER

Principal Investigators

  • Anthony Goncalves, Pr · Institut Paoli-Calmettes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-29
Primary Completion
2022-08-22
Completion
2027-08-22
FDA Drug
Yes

Countries

  • France

Study Locations

More Related Trials

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 NCT03515798 on ClinicalTrials.gov