S1007 Phase III Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER-2 Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial RX for Positive Node, Endocrine Responsive Breast Cancer
The purpose of this trial is to determine if the Oncotype DX recurrence score can help some patients and their doctors decide who should receive chemotherapy or not. Oncotype DXÂ® is a commercially available test that is performed on tumor tissue obtained at the time of surgery. It looks at multiple genes related to breast cancer and produces a score. This score can help doctors and patients make decisions about whether to include chemotherapy as part of their treatment plan. It can also help show the risk of breast cancer coming back in the future.
Women with hormone receptor (ER or PR) positive breast cancer with 1-3 positive lymph nodes who have completed their breast cancer surgery. We expect that about 8800 women will be tested to see if they can participate in the trial, and about 4000 will participate in the treatment portion of this study. About 20 women are expected to participate at Johns Hopkins.
There are two steps to taking part in this trial: Step 1: If your tissue has not already been sent for Oncotype DXÂ® testing, you will sign a consent giving us permission to have your breast cancer tissue tested. If your tissue has already been tested, you will proceed to Step 2. Patients with an Oncotype DXÂ® RS of 25 or lower will be eligible to continue with the treatment portion (Step 2) of this trial. Step 2: Patients with Oncotype DXÂ® RS of 25 or lower will be randomized (chosen at random like a flip of a coin) to receive either chemotherapy followed by endocrine therapy or endocrine therapy alone. Before starting this portion of the study you will sign an additional consent form and undergo baseline testing including standard and research blood work, CT scans, and research tissue samples. If these tests show that you are eligible you will be randomized to one of the two arms as described above. Your doctor will recommend what kind of chemotherapy and endocrine therapy that you might receive.
12/11/2013 04:02 AM