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

Breast Cancer Clinical Trial

— OTT 15-05  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02696707
• Other study ID #: 20150777-01H
• Status: Completed
• Phase: Phase 4
• Start date: June 2016
• Est. completion date: July 2020

Study information

• Verified date: March 2021
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Contraindication to transthoracic echocardiography or MUGA

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LVEF results	Changes in LVEF results compared to baseline (by echocardiography or MUGA) throughout the course of trastuzumab based therapy	at year one