Trial Outcomes & Findings for An Integrated Consent Model Study to Compare Two Standard of Care Schedules for Monitoring Cardiac Function in Patients Receiving Trastuzumab for Early Stage Breast Cancer (NCT NCT02696707)

Results Overview

Changes in Left Ventricular Ejection Fraction (LVEF) results compared to baseline (by echocardiography or MUGA) throughout the course of trastuzumab based therapy. LVEF is measured as a percentage. The outcome is a change in LVEF percentage (%).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

200 participants

Primary outcome timeframe

Baseline to 1 year

Results posted on

2025-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	LVEF 3 Month cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months LVEF 3 month: cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months	LVEF 4 Month cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months LVEF 4 month: cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months
Per Protocol Population STARTED	100	100
Per Protocol Population COMPLETED	98	97
Per Protocol Population NOT COMPLETED	2	3
Completed Study as Planned STARTED	98	97
Completed Study as Planned COMPLETED	90	88
Completed Study as Planned NOT COMPLETED	8	9

Reasons for withdrawal

Reasons for withdrawal
Measure	LVEF 3 Month cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months LVEF 3 month: cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months	LVEF 4 Month cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months LVEF 4 month: cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months
Per Protocol Population Physician Decision	2	1
Per Protocol Population Participant Decision	0	2
Completed Study as Planned Reason = LVEF	2	2
Completed Study as Planned Protocol Violation	2	6
Completed Study as Planned Metastatic disease	3	0
Completed Study as Planned Location	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LVEF 3 Month n=98 Participants cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months LVEF 3 month: cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months	LVEF 4 Month n=97 Participants cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months LVEF 4 month: cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months	Total n=195 Participants Total of all reporting groups
Age, Continuous	55.4 years STANDARD_DEVIATION 11.4 • n=98 Participants	54.8 years STANDARD_DEVIATION 11.3 • n=97 Participants	55.1 years STANDARD_DEVIATION 11.4 • n=195 Participants
Sex: Female, Male Female	98 Participants n=98 Participants	97 Participants n=97 Participants	195 Participants n=195 Participants
Sex: Female, Male Male	0 Participants n=98 Participants	0 Participants n=97 Participants	0 Participants n=195 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Baseline Left Ventricular Ejection Fraction (LVEF)	65 LVEF Percentage (%) n=98 Participants	64 LVEF Percentage (%) n=97 Participants	65 LVEF Percentage (%) n=195 Participants
Anthracycline-based chemotherapy	53 Participants n=98 Participants	50 Participants n=97 Participants	103 Participants n=195 Participants

PRIMARY outcome

Timeframe: Baseline to 1 year

Population: Per Protocol Population

Changes in Left Ventricular Ejection Fraction (LVEF) results compared to baseline (by echocardiography or MUGA) throughout the course of trastuzumab based therapy. LVEF is measured as a percentage. The outcome is a change in LVEF percentage (%).

Outcome measures

Outcome measures
Measure	LVEF 3 Month n=98 Participants cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months LVEF 3 month: cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months	LVEF 4 Month n=97 Participants cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months LVEF 4 month: cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months
LVEF Results	-8 LVEF Percentage (%) Interval -26.0 to 17.0	-6 LVEF Percentage (%) Interval -33.0 to 10.0

SECONDARY outcome

Timeframe: 1 year

The number of participants who had a delay and/or discontinuation in trastuzumab treatment. Data was collected from physicians following clinic visits and from patient electronic medical records.

Outcome measures

Outcome measures
Measure	LVEF 3 Month n=98 Participants cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months LVEF 3 month: cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months	LVEF 4 Month n=97 Participants cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months LVEF 4 month: cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months
Rates of Trastuzumab Delay and Discontinuation Delay	9 Participants	2 Participants
Rates of Trastuzumab Delay and Discontinuation Discontinuation	2 Participants	7 Participants

SECONDARY outcome

Timeframe: 1 year

The number of participants who were referred to cardiology. Data was collected from physicians following clinic visits, and from the patient's electronic medical record.

Outcome measures

Outcome measures
Measure	LVEF 3 Month n=98 Participants cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months LVEF 3 month: cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months	LVEF 4 Month n=97 Participants cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months LVEF 4 month: cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months
Referral to Cardiology	12 Participants	12 Participants

SECONDARY outcome

Timeframe: 1 year

The number of participants who experienced a decrease in ejection fraction (EF), congestive heart failure, or other cardiac events within the 1 year of study. Examples of other cardiac events include change in blood pressure, chest pain/shortness of breath, or irregular heartbeat. Data was collected/reported from physicians following clinic appointments, and from the patient's electronic medical record.

Outcome measures

Outcome measures
Measure	LVEF 3 Month n=98 Participants cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months LVEF 3 month: cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months	LVEF 4 Month n=97 Participants cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months LVEF 4 month: cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months
Rate of Cardiac Events	31 Participants	24 Participants

Adverse Events

LVEF 3 Month

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LVEF 4 Month

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Hilton

Ottawa Hospital Research Institute

Phone: 613-737-7700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place