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Telemonitoring Platform "CUREETY TECHCARE" vs Standard of Care for mTBNC Patients Initiating a First-line Treatment

Study acronym: ALTERNATIVE
StatusTerminated
PhaseNot applicable
SponsorUNICANCER
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial terminated Sponsor's reason: The study was terminated prematurely due to insufficient patient recruitment. Final enrollment: 31 participants — 7% of the 472 planned · Primary completion date changed from estimate of Sep 1, 2026 to Dec 1, 2025 · Study completion date changed from estimate of Sep 2, 2028 to Dec 12, 2025 · 3 more Show 6 more changesShow less
    • Final enrollment: 31 participants — 7% of the 472 planned
    • Primary completion date changed from estimate of Sep 1, 2026 to Dec 1, 2025
    • Study completion date changed from estimate of Sep 2, 2028 to Dec 12, 2025
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 7 of 12 entries
    • Site details revised at 51 of 51 sites
  2. Primary completion date: May 2, 2026 to Sep 1, 2026 Completion date: Sep 2, 2027 to Sep 2, 2028v3 Show 1 more changeShow less
    • Completion date: Sep 2, 2027 to Sep 2, 2028
  3. Phase: Phase 3 to Not applicable Trial status: Not Yet Recruiting to Recruiting · Start date changed from estimate of Jul 12, 2024 to Jul 25, 2024 · Site details revised at 51 of 51 sitesv2 Show 3 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 12, 2024 to Jul 25, 2024
    • Site details revised at 51 of 51 sites
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this clinical trial is to assess whether adding telemonitoring (the digital telemonitoring platform "CUREETY TECHCARE"), to standard care, will benefit patients with previously untreated metastatic triple-negative breast cancer starting first-line cancer therapy. The main questions it aims to answer are: * Is patient quality of life improved by using the telemonitoring platform? * Are patients hospitalized less frequently when using the telemonitoring platform? * Is the patient overall survival improved by telemonitoring ? Researchers will compare data from patients using telemonitoring while receiving standard care with data from patients receiving only standard care. Participants using telemonitoring will answer questions about their symptoms on the platform. The platform will analyze these symptoms, assess the patient's general condition and provide advice accordingly. Medical staff will also access the platform to monitor the patient's general condition and contact them if necessary.
Trial Details
NCT Number NCT06505018
Lead Sponsor UNICANCER
Collaborators: Cureety
Conditions Metastatic Triple-Negative Breast Carcinoma
Enrollment 31 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov