NCT02696707

Brief Summary

Several large adjuvant trastuzumab trials have demonstrated improved overall survival in participants with early stage breast cancer, with a 33% decrease in risk of death. However, retrospective analyses of participant outcomes in these trials have demonstrated increased risk of cardiotoxicity (i.e damage to the heart) in a small number of patients (4-8%). At this time, investigators are unable to predict which participants are at increased risk of cardiac-related treatment complications. Currently all patients receive regular cardiac imaging throughout their one year of trastuzumab treatment. At this time, the optimal monitoring schedule for trastuzumab-related cardiotoxicity remains unknown, and several published consensus guidelines are currently in use as standard of care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for phase_4 breast-cancer

Timeline
Completed

Started Jun 2016

Typical duration for phase_4 breast-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
5 years until next milestone

Results Posted

Study results publicly available

July 14, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

3.9 years

First QC Date

February 18, 2016

Results QC Date

April 1, 2025

Last Update Submit

December 5, 2025

Conditions

Breast Cancer

Keywords

cardiac toxicities

Outcome Measures

Primary Outcomes (1)

  • LVEF Results

    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 (%).

    Baseline to 1 year

Secondary Outcomes (3)

  • Rates of Trastuzumab Delay and Discontinuation

    1 year

  • Referral to Cardiology

    1 year

  • Rate of Cardiac Events

    1 year

Study Arms (2)

LVEF 3 month

ACTIVE COMPARATOR

cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months

Procedure: LVEF 3 month

LVEF 4 month

ACTIVE COMPARATOR

cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months

Procedure: LVEF 4 month

Interventions

LVEF 3 monthPROCEDURE

cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months

LVEF 3 month
LVEF 4 monthPROCEDURE

cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months

LVEF 4 month

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed early stage HER2-positive breast cancer
  • Planned trastuzumab therapy for early stage breast cancer
  • ≥18 years of age
  • Able to provide verbal consent
  • Normal LVEF (\>53%) before trastuzumab therapy

You may not qualify if:

  • Contraindication to transthoracic echocardiography or MUGA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K2H 8L6, Canada

Location

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Related Publications (1)

  • Dent S, Fergusson D, Aseyev O, Stober C, Pond G, Awan AA, McGee SF, Ng TL, Simos D, Vandermeer L, Saunders D, Hilton JF, Hutton B, Clemons M. A Randomized Trial Comparing 3- versus 4-Monthly Cardiac Monitoring in Patients Receiving Trastuzumab-Based Chemotherapy for Early Breast Cancer. Curr Oncol. 2021 Dec 3;28(6):5073-5083. doi: 10.3390/curroncol28060427.

    PMID: 34940066RESULT

Related Links

MeSH Terms

Conditions

Breast NeoplasmsCardiotoxicity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Results Point of Contact

Title
Dr. John Hilton
Organization
Ottawa Hospital Research Institute
jfhilton@toh.ca
613-737-7700

Study Officials

  • Olexiy Aseyey, MD

    The Ottawa Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2016

First Posted

March 2, 2016

Study Start

June 1, 2016

Primary Completion

May 1, 2020

Study Completion

July 1, 2020

Last Updated

December 18, 2025

Results First Posted

July 14, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(4)