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Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction

Study acronym: SCHOLAR-2
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 6, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jan 1, 2025 to Dec 31, 2025 Completion date: Jun 1, 2025 to Jun 30, 2026 · Site details revised at 2 of 8 sitesv8 Show 2 more changesShow less
    • Completion date: Jun 1, 2025 to Jun 30, 2026
    • Site details revised at 2 of 8 sites
  2. Primary completion date: Jan 1, 2024 to Jan 1, 2025 Completion date: Dec 1, 2025 to Jun 1, 2025v7 Show 1 more changeShow less
    • Completion date: Dec 1, 2025 to Jun 1, 2025
  3. Study sites: 4 to 8v6
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 4 · Completion date: Jan 1, 2025 to Dec 1, 2025 · Start date changed from estimate of May 1, 2021 to Jul 1, 2021v5 Show 3 more changesShow less
    • Study sites: 0 to 4
    • Completion date: Jan 1, 2025 to Dec 1, 2025
    • Start date changed from estimate of May 1, 2021 to Jul 1, 2021
  5. Start date: Mar 1, 2021 to May 1, 2021v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Jan 1, 2021 to Mar 1, 2021v3
  2. Secondary endpoint revisedv2 See this version in full on ClinicalTrials.gov ↗
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Trastuzumab is an important treatment for HER 2 positive breast cancer. But trastuzumab can cause injury to the heart, and this is one of the main reasons it cannot be administered as planned. Heart injury can often be successfully treated using cardiac medications. The objectives of SCHOLAR-2 are to evaluate whether is it safe and effective to continue trastuzumab, pertuzumab or trastuzumab-emtansine (T-DM1) in patients with early stage HER-2 positive breast cancer despite mild, minimally symptomatic or asymptomatic systolic left ventricular dysfunction as compared with a guideline-driven approach of withholding or discontinuing trastuzumab, pertuzumab or trastuzumab-emtansine (T-DM1). In SCHOLAR-2, we will compare two thresholds of withholding or discontinuing trastuzumab/pertuzumab/trastuzumab-emtansine: a threshold that is currently advocated for by existing treatment practice guidelines versus a more aggressive threshold that allows trastuzumab/pertuzumab/trastuzumab-emtansine to continue at lower levels of LVEF than currently supported by guideline documents.
Trial Details
NCT Number NCT04680442
Lead Sponsor Population Health Research Institute
Conditions Breast Cancer, Heart Failure
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov