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)

O

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)

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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