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Neo Adjuvant Chemotherapy in Triple Negative Breast Cancer

Study acronym: neo-TN
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 12, 2022 (before its estimated June 2023 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jun 2022 to Jun 2023v15
  2. Primary completion date: Jun 2021 to Jun 2022v14
  3. Primary completion date: Dec 2020 to Jun 2021v13
  4. Primary completion date: Dec 2019 to Dec 2020v12
  5. Completion date: Dec 2029v11
Show 9 earlier versionsHide 9 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 270 to confirmed 310 · Site details revised at 14 of 14 sitesv10 Show 2 more changesShow less
    • Enrollment target: estimated 270 to confirmed 310
    • Site details revised at 14 of 14 sites
  2. Primary completion date: Dec 2015 to Dec 2019v9
  3. Re-verified, no change to tracked fieldsv8
  4. Primary completion date: Jan 2015 to Dec 2015 Study sites: 12 to 14 · Interventions: Docetaxel, Capecitabine (Drug), Doxorubicin, cyclophosphamide (Drug), Doxorubicin, cyclophosphamide, carboplatin, thiotepa… to Carboplatin and Paclitaxel (Drug), Doxorubicin, cyclophosphamide (Drug), Doxorubicin, cyclophosphamide, carboplatin, thiotepa… · Study arms: 6 to 5v7 Show 3 more changesShow less
    • Study sites: 12 to 14
    • Interventions: Docetaxel, Capecitabine (Drug), Doxorubicin, cyclophosphamide (Drug), Doxorubicin, cyclophosphamide, carboplatin, thiotepa… to Carboplatin and Paclitaxel (Drug), Doxorubicin, cyclophosphamide (Drug), Doxorubicin, cyclophosphamide, carboplatin, thiotepa…
    • Study arms: 6 to 5
  5. Study sites: 10 to 12v6
  6. 3 versions Re-verified since Jul 28, 2011, no change to tracked fieldsv3-v5
  7. Site details revised at 5 of 10 sitesv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study aims to compare the response of triple-negative breast cancer with deficient homologous recombination to intensified alkylating chemotherapy versus standard chemotherapy with dose dense AC and/or Docetaxel-Capecitabine.
Trial Details
NCT Number NCT01057069
Lead Sponsor The Netherlands Cancer Institute
Conditions Breast Cancer
Enrollment 310 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov