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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 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 239-participant average among 54 other HER2-positive Breast Cancer trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 1 state.

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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.

Conditions Studied

HER2-positive Breast Cancer Left Ventricular Function Systolic Dysfunction

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

FieldValue
Enrollment Target 31 participants
Start Date 2013-10
Est. Completion 2020-06
Phase Phase 2

Sponsor

Medstar Health Research Institute

115 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01904903

The ClinicalTrials.gov registry entry for NCT01904903 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 54 other HER2-positive Breast Cancer trials with a reported enrollment target (87% lower). The listed sponsor is Medstar Health Research Institute, which has 115 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.