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NCT01904903 · ClinicalTrials.gov registry record · Phase 2
Cardiac Safety Study in Patients With HER2 + Breast Cancer
A Phase 2 study of HER2-positive Breast Cancer and Left Ventricular Function Systolic Dysfunction, sponsored by Medstar Health Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
- 2
- Study locations
NCT01904903: Completed Phase 2 study of HER2-positive Breast Cancer and Left Ventricular Function Systolic Dysfunction, sponsored by Medstar Health Research Institute.
NCT01904903 is a Phase 2 study of HER2-positive Breast Cancer and Left Ventricular Function Systolic Dysfunction that has completed, run by Medstar Health Research Institute. The registered enrollment target is 31 participants, below the 235-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01904903, a Phase 2 study of HER2-positive Breast Cancer and Left Ventricular Function Systolic Dysfunction, has completed, sponsored by Medstar Health Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
- 2
- Study locations
Study Summary
HER2 positive breast cancer cells have more HER2 receptor (a protein on the surface of cells) than normal breast cells. Approximately 30% of patients with breast cancer have HER2 positive breast cancer. Before HER2 targeted therapies (i.e. treatments that directly block the receptor HER2) were developed, patients with HER2 positive breast cancer had a very aggressive form of disease. With the use of trastuzumab, an anticancer drug that directly targets the receptor HER2, and more recently, pertuzumab and ado-trastuzumab emtansine, patients are able to live longer and have better control of their cancer. Unfortunately the use of HER2 targeted therapies can increase the risk of heart problems and for this reason these treatments were only studied and approved for patients with normal heart function. In this study we plan to give HER2 targeted therapies to patients with HER2 positive breast cancer and mildly decreased heart function along with concomitant evaluation by a heart doctor (called cardiologist) and appropriate medications to strengthen the heart. We will do frequent monitoring of the heart function with a test called echocardiogram that will give us a detailed "picture" of the heart. We will also draw blood along with routine blood tests to try to understand why some patients develop heart problems and others do not. The study will take a maximum of 12 months and patients will be monitored for 6 additional months. We hypothesize that it is safe to administer HER2 targeted therapies to patients with breast cancer and mildly decreased heart function, i.e. LVEF between 40 and 50%, while on appropriate heart medications.
Primary Outcome
Cardiac events are defined as any of the following: * Presence of symptoms attributable to heart failure as confirmed by a cardiologist * Cardiac arrhythmia requiring pharmacological or electrical treatment * Myocardial infarction * Sudden cardiac death or death due to myocardial infarct, arrhythmia or heart failure Asymptomatic worsening of cardiac function defined as: \- Asymptomatic decline in LVEF \> 10% points from baseline and/or EF \< 35% corroborated by a confirmatory echocardiogram i
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Pertuzumab
- DRUG Ado Trastuzumab Emtansine
Study Locations (2)
District of Columbia
- Washington Cancer Institute at MedStar Washington Hospital Center - Washington D.C.
- MedStar Georgetown University Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2013-10 |
| Est. Completion | 2020-06 |
| Phase | Phase 2 |
What the finished NCT01904903 record still lists
NCT01904903 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 235-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Trastuzumab is the first listed.
NCT01904903 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT01904903 about?
NCT01904903 is a clinical study titled "Cardiac Safety Study in Patients With HER2 + Breast Cancer". HER2 positive breast cancer cells have more HER2 receptor (a protein on the surface of cells) than normal breast cells. Approximately 30% of patients with breast cancer have HER2 positive breast cancer. Before HER2 targeted therapies (i.e. treatments that directly block the receptor HER2) were devel...
What is the current status of trial NCT01904903?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2013-10. Estimated completion is 2020-06.
What conditions does trial NCT01904903 study?
This clinical trial studies the following conditions: HER2-positive Breast Cancer, Left Ventricular Function Systolic Dysfunction.
What interventions are being tested in trial NCT01904903?
The interventions under investigation include: Trastuzumab (DRUG), Pertuzumab (DRUG), Ado Trastuzumab Emtansine (DRUG).
Who is sponsoring clinical trial NCT01904903?
This trial is sponsored by Medstar Health Research Institute, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01904903 being conducted?
This trial has 2 study locations across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01904903's enrollment target sits among peer trials
31 39th of 58 higher than 19 of 58 other HER2-positive Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-positive Breast Cancer 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.
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