Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer

StatusNot Yet Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 2 months later Aug 31, 2030 → Oct 31, 2030
See other at-risk trials from Washington University School of Medicine

Record History

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  1. Notable Start date: Aug 31, 2026 to Oct 31, 2026 Show 4 more changesShow less
    • Primary completion pushed from Aug 31, 2030 to Oct 31, 2030
    • Study completion pushed from Aug 31, 2031 to Oct 31, 2031
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints: details revised at 2 of 4 entries
  2. Minor Collaborators expanded, about 4 wordsv2
  3. Minor Study First Submitted
  • 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 purpose of this study is to evaluate use of lovastatin, a drug that may lower CAV-1 levels, in order to increase HER2 expression on cells and enhance the uptake and efficacy of trastuzumab deruxtecan (T-DXd) in HER2-low and ultralow advanced metastatic breast cancer. Trastuzumab deruxtecan (T-DXd) is an FDA approved antibody drug conjugate for HER2-low and ultralow breast cancer and lovastatin is a cholesterol lowering agent.
Trial Details
NCT Number NCT07619365
Lead Sponsor Washington University School of Medicine
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)
Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer
Related terms Breast Neoplasms
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov