Breast Cancer
Conditions
Brief summary
This study retrospectively looks at changes in Echocardiographic parameters while using transtuzumab
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.
Interventions
None listed
Sponsors
Texas Tech University Health Sciences Center, El Paso
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Inclusion criteria
* Stage 1,2,3 breast cancer * Her2+
Exclusion criteria
* Stage 4 cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LVEF | Baseline (prior to therapy), at 3-6 months (mid-therapy), and at 1 year (end of therapy) | LV ejection fraction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Hospitalized for Cardiac Issues. | 1 year | any hospitalization for cardiac issues |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Trastuzumab-treated Breast Cancer Patients Patients with early stage (1,2,3) HER 2 + breast cancer, treated with trastuzumab | 60 |
| Trastuzumab-treated Breast Cancer Patients Patients with early stage (1,2,3) HER 2 + breast cancer, treated with trastuzumab | 180 |
| Total | 240 |
Baseline characteristics
| Characteristic | Trastuzumab-treated Breast Cancer Patients |
|---|---|
| Age, Continuous | 61 years |
| Left ventricular ejection fraction | 65.4 % STANDARD_DEVIATION 0.844 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 56 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 2 / 60 |
Outcome results
Primary
LVEF
LV ejection fraction
Time frame: Baseline (prior to therapy), at 3-6 months (mid-therapy), and at 1 year (end of therapy)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients | LVEF | 65.4 percentage of blood in left ventricle | Standard Deviation 0.844 |
| LVEF at 3-6months | LVEF | 64.7 percentage of blood in left ventricle | Standard Deviation 0.724 |
| LVEF End of Therapy | LVEF | 62.2 percentage of blood in left ventricle | Standard Deviation 0.81 |
p-value: <0.0005ANOVA
Secondary
Number of Participants Hospitalized for Cardiac Issues.
any hospitalization for cardiac issues
Time frame: 1 year
Population: patients receiving transtuzumab
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients | Number of Participants Hospitalized for Cardiac Issues. | 0 Participants |