Cardiac Safety Study in Patients With HER2 + Breast Cancer
Status:
Completed
Trial end date:
2020-06-01
Target enrollment:
Participant gender:
Summary
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, an anticancer drug that directly
targets the receptor HER2, and more recently, pertuzumab and ado-trastuzumab emtansine,
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.
Phase:
Phase 2
Details
Lead Sponsor:
Medstar Health Research Institute Washington Hospital Center