Trial of Standard Adjuvant Endocrine Therapy with or without chemotherapy
This is for women with hormone-responsive breast cancer with 1-3 positive lymph nodes. The purpose of this study is to find out if the Oncotype DX Recurrence Score can help decide whether patients should receive chemotherapy or not. The Oncotype DX is a test that looks at multiple genes related to breast cancer and the risk of cancer coming back. Your breast cancer tissue from surgery is collected and sent to a special laboratory for this testing. The Oncotype DX is used to determine whether you are eligible to continue to the treatment part of this clinical trial. If the recurrence score is higher than 25, the risk that cancer will come back is higher and other treatment options will be discussed with your doctor. If the recurrence score is 25 or lower, you are eligible for the study. You will receive either hormonal therapy and chemotherapy or hormonal therapy alone. These will be standard offerings selected by you and your physician.
If you are eligible to participate in this study you will be randomized into 2 groups. In Arm 1 you will receive a study approved chemotherapy and hormone medication. If you are selected for Arm 2 you will receive only hormonal medicine. The choice of medications within the arms will be selected by you and your doctor. You may continue on the study for up to 10 years and could remain in follow up visits up to 15 years. During the study you will be required to have physical exams, blood tests, mamograms and a test to determine the ability of your heart to pump to determine how your disease is responding to the medication(s) and to evaluate for any side effects.
Oncotype Recurrence Score of 25 or less Females 18 years or older No spread of cancer from the breast to other areas The breast cancer must have already been removed by surgery Patients must have completed surgery no sooner than 28 days or more than 56 days before starting medication
Nina D'Abreo, MD
Patricia Ly RN MSN ANP firstname.lastname@example.org