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This study retrospectively looks at changes in Echocardiographic parameters while using transtuzumab
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.
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| Measure | Description | Time Frame |
|---|---|---|
| LVEF | LV ejection fraction | Baseline (prior to therapy), at 3-6 months (mid-therapy), and at 1 year (end of therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Hospitalized for Cardiac Issues. | any hospitalization for cardiac issues | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Early stage HER 2 + breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Sumit Gaur | TTUHSC El Paso | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ttuhsc | El Paso | Texas | 79905 | United States |
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Retrospective review of medical charts of HER 2 positive, stage 1,2 and 3 breast cancer at Univesity medical center, TTUHSC-EL Paso between Jan 1 2010 and Jan 1 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trastuzumab-treated Breast Cancer Patients | Patients with early stage (1,2,3) HER 2 + breast cancer, treated with trastuzumab |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Trastuzumab-treated Breast Cancer Patients | Patients with early stage (1,2,3) HER 2 + breast cancer, treated with trastuzumab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | LVEF | LV ejection fraction | Posted | Mean | Standard Deviation | percentage of blood in left ventricle | Baseline (prior to therapy), at 3-6 months (mid-therapy), and at 1 year (end of therapy) |
|
1 year
EF decline Hospitalization for cardiac complications
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trastuzumab-treated Breast Cancer Patients | Patients with early stage (1,2,3) HER 2 + breast cancer, treated with trastuzumab |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LVEF decline | Cardiac disorders | Non-systematic Assessment | decline in LVEF during therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sumit Gaur | TTUHSC-El Paso | 9152155200 | sumit.gaur@ttuhsc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2017 | Apr 15, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| LVEF (3 measures per patient) |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| Left ventricular ejection fraction | Percentage of blood in left ventricle ejected. | Mean | Standard Deviation | % | Participants |
|
|
|
|
| Secondary | Number of Participants Hospitalized for Cardiac Issues. | any hospitalization for cardiac issues | patients receiving transtuzumab | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 0 |
| 60 |
| 2 |
| 60 |
| 0 |
| 60 |
|
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| D017437 |
| Skin and Connective Tissue Diseases |