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Adjuvant Treatment of EC Followed by Taxane +/- Carboplatin in Triple-Negative Breast Cancer

Study acronym: TCTN
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Dec 2022 to Mar 2027v11 Show 6 more changesShow less
    • Start date: Jul 2015 to Mar 2016
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 970 to confirmed 786
    • Study completion date: Dec 2023 to Mar 2030
    • Secondary endpoints revised (3)
    • Site details revised at 27 of 27 sites
  2. Primary completion date: Jun 2021 to Dec 2022v10
  3. Primary completion date: Jun 2020 to Jun 2021
    • Study completion date: Dec 2020 to Dec 2023
    v9
  4. Study sites: 28 to 27v8
  5. Study sites: 17 to 28v7
Show 5 earlier versionsHide 5 earlier versions
  1. Eligibility criteria revisedv6
  2. Study sites: 14 to 17v5 Show 4 more changesShow less
    • Interventions: Epirubicin plus Cyclophosphamide (Drug), Paclitaxel (Drug), Paclitaxel plus Carboplatin (Drug) to Epirubicin plus Cyclophosphamide (Drug), Taxanes (Drug), Taxanes plus Carboplatin (Drug)
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description revised
    • Study title revised
  3. Re-verified, no change to tracked fieldsv4
  4. Study sites: 6 to 14v3
  5. Phase: Phase 2 to Phase 3v2 Show 10 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Enrollment target: 300 to 970
    • Primary completion date: Jun 2018 to Jun 2020
    • Study sites: 1 to 6
    • Study completion date: Jun 2020 to Dec 2020
    • Start date: Jun 2015 to Jul 2015
    • Interventions: Docetaxel (Drug), Epirubicin plus Cyclophosphamide (Drug), Paclitaxel (Drug), Paclitaxel plus Carboplatin (Drug) to Epirubicin plus Cyclophosphamide (Drug), Paclitaxel (Drug), Paclitaxel plus Carboplatin (Drug)
    • Study description shortened, about 21 words
    • Study arms: 3 to 2
    • Study title shortened, about 2 words
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To compare disease-free survival (DFS) rate of adjuvant chemotherapy epirubicin-cyclophosphamide followed by weekly paclitaxel or docetaxel (EC-T), or weekly paclitaxel or docetaxel-carboplatin (EC-TCb) in triple-negative breast cancer.
Trial Details
NCT Number NCT02455141
Lead Sponsor Shanghai Jiao Tong University School of Medicine
Conditions
(from sponsor)		 Breast Neoplasm
Related terms Breast Neoplasms
Enrollment 786 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov