Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01009918 · ClinicalTrials.gov registry record · Phase 2
Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab
A Phase 2 study, sponsored by University of South Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 468
- Enrollment target
NCT01009918: Completed Phase 2 study, sponsored by University of South Florida.
NCT01009918 is a Phase 2 study that has completed, run by University of South Florida. The registered enrollment target is 468 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (252% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01009918, a Phase 2 study, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 468 participants
- Enrollment target
Study Summary
RATIONALE: Lisinopril or Coreg CR®, may help reduce side effects caused by trastuzumab. It is not yet known whether lisinopril or Coreg CR® are more effective than a placebo in reducing side effects caused by trastuzumab. PURPOSE: This phase II trial is studying lisinopril and Coreg CR® to see how well they work compared with a placebo in reducing side effects in patients with HER2-positive breast cancer receiving trastuzumab.
Primary Outcome
Reduction in incidence of trastuzumab-induced cardiotoxicity after 52 weeks of treatment as measured by preservation of Left Ventricular Ejection Fraction (LVEF). Number of Patients who experienced a cardiotoxicity.
Interventions
- OTHER placebo
- DRUG lisinopril
- DRUG Coreg CR®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 468 participants |
| Start Date | 2010-03 |
| Est. Completion | 2018-11 |
| Phase | Phase 2 |
What the finished NCT01009918 record still lists
NCT01009918 is an interventional study that assigns participants to a tested intervention. The registered 468 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (252% higher).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT01009918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01009918 about?
NCT01009918 is a clinical study titled "Lisinopril or Coreg CR® in Reducing Side Effects in Women With Breast Cancer Receiving Trastuzumab". RATIONALE: Lisinopril or Coreg CR®, may help reduce side effects caused by trastuzumab. It is not yet known whether lisinopril or Coreg CR® are more effective than a placebo in reducing side effects caused by trastuzumab. PURPOSE: This phase II trial is studying lisinopril and Coreg CR® to see how ...
What is the current status of trial NCT01009918?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 468 participants. The study started on 2010-03. Estimated completion is 2018-11.
What interventions are being tested in trial NCT01009918?
The interventions under investigation include: placebo (OTHER), lisinopril (DRUG), Coreg CR® (DRUG).
Who is sponsoring clinical trial NCT01009918?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01009918's enrollment target sits among peer trials
468 80th of 2000 higher than 1,921 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
- NCT03124303 · 468 participants
Interventions for Postoperative Delirium: Biomarker-3
- NCT03901924 · 468 participants · NA
Volume Support/Assist Control Mode Ventilation and Diaphragmatic Atrophy
- NCT04482309 · 468 participants · Phase 2
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
- NCT05357170 · 468 participants
Microbiome Dysfunction in Surgical Intensive Care Unit Survivors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia