Trial Outcomes & Findings for A Study of Limited Heart Monitoring During Non-anthracycline Trastuzumab-based Therapy in Breast Cancer Patients (NCT NCT03983382)

Last Updated: 2025-05-01

Results Overview

Recruitment status

ACTIVE_NOT_RECRUITING

Target enrollment

190 participants

Primary outcome timeframe

12 months from baseline

Results posted on

2025-05-01

Participant milestones
Measure	HER2-Positive Breast Cancer Left Ventricular Ejection Fraction: LVEF assessment at baseline, 6 months, and 12 months
Overall Study STARTED	190
Overall Study COMPLETED	172
Overall Study NOT COMPLETED	18

Reasons for withdrawal
Measure	HER2-Positive Breast Cancer Left Ventricular Ejection Fraction: LVEF assessment at baseline, 6 months, and 12 months
Overall Study Death	1
Overall Study Lost to Follow-up	3
Overall Study Physician Decision	2
Overall Study Withdrawal by Subject	10
Overall Study Change in cancer treatment	2

A Study of Limited Heart Monitoring During Non-anthracycline Trastuzumab-based Therapy in Breast Cancer Patients

Baseline characteristics by cohort
Measure	HER2-Positive Breast Cancer n=190 Participants Left Ventricular Ejection Fraction: LVEF assessment at baseline, 6 months, and 12 months
Age, Continuous	52 years n=5 Participants
Sex: Female, Male Female	190 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	158 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	24 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	14 Participants n=5 Participants
Race (NIH/OMB) White	139 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants
Region of Enrollment United States	190 Participants n=5 Participants

Timeframe: 12 months from baseline

Outcome measures
Measure	HER2-Positive Breast Cancer n=190 Participants Left Ventricular Ejection Fraction: LVEF assessment at baseline, 6 months, and 12 months
Frequency of Cardiac Adverse Events, Defined by a Compositive of Clinical Heart Failure (NYHA Class III or IV) or Cardiac Death.	0 Cardiac AEs

Serious events: 1 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events
Measure	HER2-Positive Breast Cancer n=190 participants at risk Left Ventricular Ejection Fraction: LVEF assessment at baseline, 6 months, and 12 months
General disorders Death NOS	0.53% 1/190 • 1 years

Other adverse events
Measure	HER2-Positive Breast Cancer n=190 participants at risk Left Ventricular Ejection Fraction: LVEF assessment at baseline, 6 months, and 12 months
Cardiac disorders Left ventricular- systolic dysfunction	0.53% 1/190 • 1 years
Cardiac disorders Cardiac Disorders- Other specify	1.6% 3/190 • 1 years
General disorders Edema: Limb	1.1% 2/190 • 1 years
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	0.53% 1/190 • 1 years
Cardiac disorders Ventricular arrhythmia-Ventricular tachycardia	0.53% 1/190 • 1 years

Memorial Sloan Kettering Cancer Center

Phone: 212-639-5154