Echocardiographic Changes During Adjuvant Therapy in Hispanic Women With Her-2 Neu Expressing Breast Cancer

July 31, 2019 updated by: Sumit Gaur, Texas Tech University Health Sciences Center, El Paso
This study retrospectively looks at changes in Echocardiographic parameters while using transtuzumab

Study Overview

Status

Completed

Conditions

Detailed Description

Transtuzumab based chemo-immunotherapy is commonly administered to patients diagnosed with early stage HER-2 expressing breast cancer, because it decreases the risk of relapse.

Transtuzumab affects cardiac function and potential benefits in decreasing cancer recurrence have to be balanced against short and long term toxicity.

We have previously identified a high prevalence of metabolic syndrome and type II diabetes mellitus in our patients with breast cancer. These patients may be particularly susceptible to cardiotoxic effects of transtuzumab based therapy.

Aim of this study is to assess the changes in the cardiac function of women who are undergoing transtuzumab based therapy for early stage breast cancer.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • El Paso, Texas, United States, 79905
        • TTUHSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Early stage HER 2 + breast cancer

Description

Inclusion Criteria:

  • Stage 1,2,3 breast cancer
  • Her2+

Exclusion Criteria:

  • Stage 4 cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LVEF
Time Frame: Baseline (prior to therapy), at 3-6 months (mid-therapy), and at 1 year (end of therapy)
LV ejection fraction
Baseline (prior to therapy), at 3-6 months (mid-therapy), and at 1 year (end of therapy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Hospitalized for Cardiac Issues.
Time Frame: 1 year
any hospitalization for cardiac issues
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Tech University Health Sciences Center, El Paso

Investigators

  • Principal Investigator: Sumit Gaur, TTUHSC El Paso

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2017

Primary Completion (Actual)

February 26, 2019

Study Completion (Actual)

February 26, 2019

Study Registration Dates

First Submitted

April 18, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (Actual)

April 21, 2017

Study Record Updates

Last Update Posted (Actual)

September 9, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E17080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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