NCT01904903 (SAFE-HEaRt) (Clinical Trial/ Ado-Trastuzumab Emtansine)

Study Title
Cardiac Safety Study in Patients With HER2 + Breast Cancer (SAFE-HEaRt) (NCT01904903)

Trial Description
HER2 positive breast cancer cells have more HER2 receptor (a protein on the surface of cells) than normal breast cells. Approximately 30% of patients with breast cancer have HER2 positive breast cancer. Before HER2 targeted therapies (i.e. treatments that directly block the receptor HER2) were developed, patients with HER2 positive breast cancer had a very aggressive form of disease. With the use of trastuzumab (Herceptin®;Genentech, Inc.), an anticancer drug that directly targets the receptor HER2, and more recently, pertuzumab (Perjeta®; Genentech, Inc.) and ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.), patients are able to live longer and have better control of their cancer.

Unfortunately the use of HER2 targeted therapies can increase the risk of heart problems and for this reason these treatments were only studied and approved for patients with normal heart function.

In this study we plan to give HER2 targeted therapies to patients with HER2 positive breast cancer and mildly decreased heart function along with concomitant evaluation by a heart doctor (called cardiologist) and appropriate medications to strengthen the heart. We will do frequent monitoring of the heart function with a test called echocardiogram that will give us a detailed “picture” of the heart. We will also draw blood along with routine blood tests to try to understand why some patients develop heart problems and others do not. The study will take a maximum of 12 months and patients will be monitored for 6 additional months.

We hypothesize that it is safe to administer HER2 targeted therapies to patients with breast cancer and mildly decreased heart function, i.e. LVEF between 40 and 50%, while on appropriate heart medications.

This trial is sponsored by Washington Hospital CenterGenentech, Inc.

Study Data

  • Condition: 
    • HER2 Positive Breast Cancer
    • Left Ventricular Function Systolic Dysfunction
  • Interventions:
  • Phase: II
  • Estimated Enrollment: 30
  • Start: August 2013
  • Estimated Completion: August 2018
  • Last verified: February 2015

Study Schematic

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Last Editorial review: July 31, 2015
Information based on (NIH/NCI) and other sources.

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