Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05552001 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer

Study acronym: ISIdE
StatusActive, Not Recruiting
PhasePhase 3
SponsorUNICANCER
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 21, 2026 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Primary completion date: May 1, 2026 to Oct 1, 2026 · Site details revisedv8 Show 2 more changesShow less
    • Primary completion date: May 1, 2026 to Oct 1, 2026
    • Site details revised
  2. Primary completion date: Jun 1, 2026 to May 1, 2026 Eligibility criteria shortened, about 28 words · Study description shortened, about 30 wordsv7 Show 2 more changesShow less
    • Eligibility criteria shortened, about 28 words
    • Study description shortened, about 30 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Dec 1, 2024 to Jun 1, 2026 Completion date: May 1, 2026 to May 6, 2028v6 Show 1 more changeShow less
    • Completion date: May 1, 2026 to May 6, 2028
  4. Eligibility criteria expanded, about 48 wordsv5 See this version in full on ClinicalTrials.gov ↗
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Oct 1, 2023 to Oct 5, 2023v4 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 1, 2023 to Oct 5, 2023
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: May 1, 2023 to Oct 1, 2023 Enrollment target: 100 to 96 · Eligibility criteria expanded, about 109 wordsv3 Show 2 more changesShow less
    • Enrollment target: 100 to 96
    • Eligibility criteria expanded, about 109 words

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Jan 1, 2023 to May 1, 2023 Primary completion date: Jul 1, 2024 to Dec 1, 2024 · Completion date: Jan 1, 2026 to May 1, 2026v2 Show 2 more changesShow less
    • Primary completion date: Jul 1, 2024 to Dec 1, 2024
    • Completion date: Jan 1, 2026 to May 1, 2026
  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.
ISIdE is an European, multicentric study that aims to assess the efficacy of Sacituzumab Govitecan (SG) in locally advanced or metastatic triple-negative breast cancer where the disease has progressed despite chemotherapy or within 6 months after the end of curative treatments in order to: 1. evaluate the treatment efficacy in less pretreated patients. 2. identify biomarkers that could predict response or resistance to the drug.
Trial Details
NCT Number NCT05552001
Lead Sponsor UNICANCER
Collaborators: Gilead Sciences
Conditions Triple Negative Breast Cancer, Metastatic Breast Cancer
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov