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

NCT ID: NCT03123263

Last Updated: 2019-09-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-11

Study Completion Date

2019-02-26

Brief Summary

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This study retrospectively looks at changes in Echocardiographic parameters while using transtuzumab

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Stage 4 cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Texas Tech University Health Sciences Center, El Paso

OTHER

Sponsor Role lead

Responsible Party

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Sumit Gaur

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sumit Gaur

Role: PRINCIPAL_INVESTIGATOR

TTUHSC El Paso

Locations

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Ttuhsc

El Paso, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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E17080

Identifier Type: -

Identifier Source: org_study_id

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