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

Study acronym: PELICAN
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Re-verified, no change to tracked fieldsv6
  2. Primary completion date changed from estimate of Dec 30, 2020 to Aug 22, 2022v5 Show 5 more changesShow less
    • Start date: Jul 24, 2018 to Aug 29, 2018
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 81 to confirmed 52
    • Study sites: 18 to 12
    • Study completion date: Apr 30, 2025 to Aug 22, 2027
  3. Study sites: 21 to 18v4 Show 4 more changesShow less
    • Interventions: Pembrolizumab Injection (Drug), neoadjuvant (F)EC-paclitaxel chemotherapy (Drug) to Pembrolizumab Injection (Drug), neoadjuvant EC-paclitaxel chemotherapy (Drug)
    • Eligibility criteria shortened, about 19 words
    • Secondary endpoints: details revised at 1 of 8 entries
    • Study description revised
  4. Site details revised at 3 of 21 sitesv3
  5. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Study sites: 14 to 21
    • Start date changed from estimate of Jun 30, 2018 to Jul 24, 2018
    • Eligibility criteria expanded, about 297 words
    • Collaborators: 1 to 2
    • Publications: 1 to 72
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03515798
Lead Sponsor Institut Paoli-Calmettes
Collaborators: MSD France, Oncodistinct
Conditions
(from sponsor)		 Inflammatory Breast Cancer
Related terms Inflammatory Breast Neoplasms
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov