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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03123263
Recruitment Status : Completed
First Posted : April 21, 2017
Results First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Sumit Gaur, Texas Tech University Health Sciences Center, El Paso

Study Description
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Brief Summary:
This study retrospectively looks at changes in Echocardiographic parameters while using transtuzumab

Condition or disease
Breast Cancer

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 Design
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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Echocardiographic Changes During Adjuvant Therapy in Hispanic Women With Her-2 Neu Expressing Breast Cancer
Actual Study Start Date : April 11, 2017
Actual Primary Completion Date : February 26, 2019
Actual Study Completion Date : February 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. LVEF [ Time Frame: Baseline (prior to therapy), at 3-6 months (mid-therapy), and at 1 year (end of therapy) ]
    LV ejection fraction


Secondary Outcome Measures :
  1. Number of Participants Hospitalized for Cardiac Issues. [ Time Frame: 1 year ]
    any hospitalization for cardiac issues


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Early stage HER 2 + breast cancer
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Stage 4 cancer
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123263


Locations
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United States, Texas
Ttuhsc
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Texas Tech University Health Sciences Center, El Paso
Investigators
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Principal Investigator: Sumit Gaur TTUHSC El Paso
  Study Documents (Full-Text)

Documents provided by Sumit Gaur, Texas Tech University Health Sciences Center, El Paso:
Study Protocol and Statistical Analysis Plan  [PDF] April 7, 2017

More Information
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Responsible Party: Sumit Gaur, MD, Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier: NCT03123263    
Other Study ID Numbers: E17080
First Posted: April 21, 2017    Key Record Dates
Results First Posted: September 9, 2019
Last Update Posted: September 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases