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Completed

NCT Number: NCT03123263

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

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

Completed

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Ttuhsc

El Paso, Texas, 79905, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Stage 4 cancer

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Number of Participants Hospitalized for Cardiac Issues.

    Time frame: 1 year

    any hospitalization for cardiac issues

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center, El Paso

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 21, 2017
Registry last updated
Sep 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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