Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07619365 · ClinicalTrials.gov registry record · Phase 2
Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer
A Phase 2 study, sponsored by Washington University School of Medicine.
- Not yet
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT07619365: Clinical Trial Phase 2 study, sponsored by Washington University School of Medicine.
NCT07619365 is a Phase 2 study that has not yet begun recruiting, run by Washington University School of Medicine. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07619365, a Phase 2 study, has not yet begun recruiting, sponsored by Washington University School of Medicine.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
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.
Primary Outcome
ORR is defined as the proportion of patients who achieve complete response (CR) or partial response (PR) according to RECIST v1.1. CR is defined as disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum d
Interventions
- DRUG Trastuzumab deruxtecan
- DRUG Lovastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-08-31 |
| Est. Completion | 2031-08-31 |
| Phase | Phase 2 |
What is known before NCT07619365 opens enrollment
NCT07619365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Trastuzumab deruxtecan is the first listed.
NCT07619365 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07619365 about?
NCT07619365 is a clinical study titled "Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer". 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-DX...
What is the current status of trial NCT07619365?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2026-08-31. Estimated completion is 2031-08-31.
What interventions are being tested in trial NCT07619365?
The interventions under investigation include: Trastuzumab deruxtecan (DRUG), Lovastatin (DRUG).
Who is sponsoring clinical trial NCT07619365?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07619365's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI