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NordicTrip, a Translational Study of Preoperative Chemotherapy in TNBC

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Jul 2025 to Sep 2035
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 30, 2035 to Sep 2035
    • Site details revised at 24 of 24 sites
    v6
  2. Enrollment target: 920 to 325
    • Primary completion date: Jun 25, 2023 to Jul 2025
    • Study sites: 25 to 24
    • Collaborators: 4 to 2
    v5
  3. Enrollment target: 820 to 920v4 Show 5 more changesShow less
    • Study sites: 16 to 25
    • Study completion date: Dec 25, 2032 to Jun 30, 2035
    • Interventions: epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin (Drug), epirubicin, cyclophosphamide, paclitaxel, carboplatin (Drug) to epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin, pembrolizumab (Drug), epirubicin, cyclophosphamide, paclitaxel…
    • Eligibility criteria revised
    • Study description expanded, about 56 words
  4. Re-verified, no change to tracked fieldsv3
  5. Site details revised at 8 of 16 sitesv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Primary aim: To compare the effect on pathologic complete response (pCR) rate of adding capecitabine to carboplatin based preoperative chemotherapy in early ER-negative and HER2-negative breast cancer. Pembrolizumab is allowed in both arms after approval for TNBC 2022.
Trial Details
NCT Number NCT04335669
Lead Sponsor Lund University Hospital
Collaborators: Swedish Breast Cancer Group, Danish Breast Cancer Cooperative Group
Conditions
(from sponsor)		 Breast Cancer, Triple Negative Breast Neoplasms
Related terms Breast Neoplasms, Pathologic Complete Response, Triple Negative Breast Neoplasms
Enrollment 325 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov