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SAFE-HEaRt: HER2 Therapy in Breast Cancer with Reduced Heart Function
NCT01904903Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2013
- Primary completion
- Jun 2019
- Countries
- 1
- Modality
- Small Molecules, Antibody-Drug Conjugates (ADCs), Engineered Antibody Formats
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of trastuzumab, pertuzumab and trastuzumab emtansine in breast cancer, sponsored by MedStar Health Research Institute. Primary endpoint: Percentage of Patients Who Complete Planned Oncologic Therapy Without the Development of a Cardiac Event or Asymptomatic Worsening of Cardiac Function at 18 months. Started Oct 2013; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
HER2 therapies + Cardiac Protection
Patients receive oncologist-selected HER2 therapy (Trastuzumab, Pertuzumab, or T-DM1) concomitant with Beta-blockers and ACE-inhibitors.
03
Who it enrols
Patients with HER2-positive breast cancer and mildly decreased LVEF (40-49%) without symptomatic heart failure.
04
Endpoints
Primary
Percentage of Patients Who Complete Planned Oncologic Therapy Without the Development of a Cardiac Event or Asymptomatic Worsening of Cardiac Function
Secondary
Median Time to Development of an Event Defined as Cardiac Event or Asymptomatic Worsening of Left Ventricular Dysfunction
Absolute Changes in LVEF During HER2 Targeted Therapy Between Baseline and End of Treatment
HER2 Therapy Holds Attributed to Proportion of Patients With Symptomatic or Asymptomatic Cardiotoxicity
Correlation of Global Longitudinal Myocardial Strain With Cardiac Events and Asymptomatic Worsening of Cardiac Function
Correlation of Standard Cardiac Troponin I and Highly Sensitive Cardiac Troponin T With Cardiac Events and Asymptomatic Worsening of Cardiac Function
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