This is a 2-part clinical trial for women with hormone-responsive breast cancer with 1-3 positive lymph nodes and have a recurrence score of 25 or less.
The purpose of the first part of the study is to send patient breast cancer tissue for Oncotype DX® recurrence score testing to find out if that patient may be eligible to participate in the next part of the study. If the recurrence score is 25 or lower, the patient can consider participation in the second part of the study.
The purpose of the second part of the study is to find out if the Oncotype DX® Recurrence Score can help decide whether patients should receive chemotherapy or not. This study is being done in patients with lower Recurrence Scores (25 or less).
Currently most women who have this type of breast cancer are treated with endocrine therapy (treatment that works with hormones). Many women also receive chemotherapy. No one really knows which patients with lower Recurrence Scores need to get chemotherapy. Patients in this part of the study will receive endocrine therapy and will also be randomized to either receive chemotherapy or not receive chemotherapy (one-half will get chemotherapy and one-half will not)
If the results of the study show that the benefit for getting chemotherapy is dependent on the Recurrence Score, the study should be able to identify a Recurrence Score level where chemotherapy should be considered (and a recurrence score level where chemotherapy may not be needed).
For more information about the trial, visit the National Cancer Institute.