This trial will evaluate a molecular test, EndoPredict®, in the treatment of breast cancer.
The main outcome will be the adherence rate to EndoPredict® results. This trial is recruiting in South Carolina, USA. It is sponsored by Myriad Genetic Laboratories.
Adjuvant chemotherapy (ACT) is used in many breast cancer (BC) survivors. ACT may reduce the risk of BC recurrence. ACT is also associated with side effects and can impact quality of life. Some patients may not need ACT. It is difficult to determine which patients will benefit from extended endocrine treatment and those that will not. EndoPredict® is a molecular test designed to predict BC recurrence.
This trial will evaluate a molecular test, EndoPredict®, in the treatment of breast cancer. The main outcome will be the adherence rate to EndoPredict® results.
Who are they looking for?
The trial will recruit 400 patients with estrogen receptor (ER)-positive and HER2-negative BC. Patients must be currently undergoing endocrine therapy. Participants must also have been diagnosed with BC between 4 and 7 years ago.
Patients cannot take part in the trial if they have active cancer in another organ. Patients that have already received ACT cannot take part in the trial. Patients who have been diagnosed with BC for more than 7 years and those who have more than 3 positive lymph nodes cannot participate.
How will it work
Patients will be separated into 2 groups. This will be determined by whether or not cancer cells were present in the lymph nodes. This is called node status. EndoPredict® will be used to predict the risk of recurrence. Doctors can use the data to decide on treatment.
The main outcome will be the adherence rate to EndoPredict® results at 1 year.