Echocardiographic Changes During Adjuvant Therapy in Hispanic Women With Her-2 Neu Expressing Breast Cancer
Conditions: Breast Cancer
Sponsor: Texas Tech University Health Sciences Center, El Paso

Version: 04/07/2017 
Echocardiographic changes during transtuzumab based therapy in Hispanic women with HER-2 neu 
expressing breast cancer. 
 
Background:  
Breast cancer is a heterogeneous disease. Up to 20% of these cancers over express HER-2. HER-2 is a 
member of transmembrane Erb B family of growth factor receptors.  Her 2+ tumors are highly 
proliferative and have increased capacity to invade and disseminate. Prognosis of patients with Her 2 + 
cancers has improved due to the inclusion of anti-HER2 antibodies in their treatment regiments. 
Amongst the available agents, transtuzumab is most commonly used. 
HER-2 signaling is crucial for cardiac development during embryogenesis and for cardiac adaptation to 
stress. Hence cardiotoxicity is the main concern during treatment with anti-HER2 agents. In well selected 
patients who participated in initial clinical trials, the incidence of left ventricular ejection fraction (LVEF) 
decline after 1 year of adjuvant transtuzumab was 4.1%. The incidence of clinical congestive heart 
failure was 0.8% (1). 
The Garber Breast Care center at TTUHSC-EP serves a predominantly Hispanic population with a high 
prevalence of obesity, dyslipidemia, type II diabetes mellitus and hypertension. Due to these pre-
existing comorbidities, these women may be at a higher risk of cardiac complications during 
transtuzumab based treatment. Recent studies also suggest that obesity may be independent predictor 
of cardiotoxicity during transtuzumab based therapy. (2) 
Aim:  
The aim of the study will be to assess the echocardiographic changes during transtuzumab based 
adjuvant therapy in patients with HER 2 expressing breast cancers. 
Methods:  
All patients diagnosed with early stage (stage 1, 2 and 3) HER 2 expressing breast cancer from Jan 1st 
2010 to Jan 1st 2015 will be identified using the tumor registry. Of these patients ones who have 
undergone adjuvant or neoadjuvant transtuzumab based therapy will be the subjects of the study. 
Following patient related information will be collected: age, race, body mass index (BMI), presence or 
absence of type II diabetes mellitus and HBA1C level, hypertension, dyslipidemia, prior diagnosis of 
coronary disease or congestive heart failure, use of angiotensin enzyme inhibitors or beta blocker. 
Following tumor related features will be collected: size, nodal status, ER status, HER 2 status (IHC and/or 
FISH), location (left or right), and use of adjuvant radiotherapy.  Chemotherapy regimen used will be 
identified. 
Echocardiograms obtained on these patients before initiation and after completion of transtuzumab will 
be reviewed. Following echocardiographic parameters will be evaluated: left ventricular ejection 
fraction, global longitudinal strain, tissue doppler and pulse wave doppler evaluation for diastolic 

Version: 04/07/2017 
dysfunction, right ventricular tricuspid annular plain systolic excursion, right ventricular fractional area 
change and pulmonary artery systolic pressure. Paired t-test will be used to evaluate the data. 
Hospitalization rate for cardiac complications during and for 2 years after completion of all cancer 
therapy will be recorded. 
References: 
1. Cameron D et al. 11 years follow up of ranstuzumab after adjuvant ceotherapy in HER2-positive 
early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial. Lancet 2017;389:1195-
1205 
2. Guenancia C el al. Obesity as a risk factor for anthracycline and transtuzumab cardiotoxicity in 
breast cancer: A systemic review and meta-analysis. J Clin Oncol 2016; 34: 3157-3165