Trial Outcomes & Findings for Echocardiographic Changes During Adjuvant Therapy in Hispanic Women With Her-2 Neu Expressing Breast Cancer (NCT NCT03123263)

NCT ID: NCT03123263

Last Updated: 2019-09-09

Results Overview

LV ejection fraction

• Recruitment status: COMPLETED
• Target enrollment: 60 participants
• Primary outcome timeframe: Baseline (prior to therapy), at 3-6 months (mid-therapy), and at 1 year (end of therapy)
• Results posted on: 2019-09-09

Participant Flow

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.

Participant milestones

Measure	Trastuzumab-treated Breast Cancer Patients Patients with early stage (1,2,3) HER 2 + breast cancer, treated with trastuzumab
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Trastuzumab-treated Breast Cancer Patients n=180 LVEF (3 measures per patient) Patients with early stage (1,2,3) HER 2 + breast cancer, treated with trastuzumab
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	56 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants
Left ventricular ejection fraction	65.4 % STANDARD_DEVIATION .844 • n=5 Participants

PRIMARY outcome

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

LV ejection fraction

Outcome measures

Measure	Patients n=60 Participants LVEF prior to therapy	LVEF at 3-6months n=60 Participants Left ventricular ejection fraction at mid point	LVEF End of Therapy n=60 Participants left ventricular ejection fraction at end of therapy.
LVEF	65.4 percentage of blood in left ventricle Standard Deviation .844	64.7 percentage of blood in left ventricle Standard Deviation .724	62.2 percentage of blood in left ventricle Standard Deviation .81

SECONDARY outcome

Timeframe: 1 year

Population: patients receiving transtuzumab

any hospitalization for cardiac issues

Outcome measures

Measure	Patients n=60 Participants LVEF prior to therapy	LVEF at 3-6months Left ventricular ejection fraction at mid point	LVEF End of Therapy left ventricular ejection fraction at end of therapy.
Number of Participants Hospitalized for Cardiac Issues.	0 Participants	—	—

Adverse Events

Trastuzumab-treated Breast Cancer Patients

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Trastuzumab-treated Breast Cancer Patients n=60 participants at risk Patients with early stage (1,2,3) HER 2 + breast cancer, treated with trastuzumab
Cardiac disorders LVEF decline	3.3% 2/60 • Number of events 2 • 1 year EF decline Hospitalization for cardiac complications

Other adverse events

Adverse event data not reported

Additional Information

Sumit Gaur

TTUHSC-El Paso

Phone: 9152155200

Email: sumit.gaur@ttuhsc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place