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 (OTT 15-05)

Ottawa Hospital Research Institute

Status and phase: Completed; Phase 4

Conditions: Breast Cancer

Treatments: Procedure: LVEF 3 month; Procedure: LVEF 4 month

Study type: Interventional

Funder types: Other

Identifiers

NCT02696707

20150777-01H

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

LVEF 3 month

Active Comparator group

Description:

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

Treatment:

Procedure: LVEF 3 month

LVEF 4 month

Active Comparator group

Description:

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

Treatment:

Procedure: LVEF 4 month