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临床试验/NCT03123263
NCT03123263已完成不适用

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

Texas Tech University Health Sciences Center, El Paso1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年4月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
LVEF

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Stage 1,2,3 breast cancer

排除标准

  • Stage 4 cancer

结局指标

主要结局

LVEF

时间窗: Baseline (prior to therapy), at 3-6 months (mid-therapy), and at 1 year (end of therapy)

LV ejection fraction

次要结局

  • Number of Participants Hospitalized for Cardiac Issues.(1 year)

研究者

发起方
Texas Tech University Health Sciences Center, El Paso
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sumit Gaur

MD

Texas Tech University Health Sciences Center, El Paso

研究点 (1)

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