To compare patient-reported utilities (e.g., quality of life ) for those randomized to chemotherapy versus no chemotherapy.
To determine the impact of Oncotype DX on the initial management cost of node-positive, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. To determine the impact of management with Oncotype DX on patient-reported anxiety (co-primary Health-Related Quality of Life outcome) prior to screening, after disclosure of test results, and during the randomized trial. To perform other molecular assays or test other signatures that measure prognosis and potential benefit of chemotherapy and compare them to Oncotype DX. To compare the toxicity across the treatment arms. To compare overall survival (OS), distant disease-free survival (DDFS) and local disease-free interval (LDFI) by receipt of chemotherapy or not and its interaction with RS. To determine the effect of chemotherapy in patients with node positive breast cancer who do not have high recurrence scores (RS) by Oncotype DX. Condition or diseaseīreast Ductal Carcinoma In Situ Invasive Breast Carcinoma Multicentric Breast Carcinoma Multifocal Breast Carcinoma Synchronous Bilateral Breast Carcinomaĭrug: Anastrozole Drug: Exemestane Other: Laboratory Biomarker Analysis Drug: Letrozole Other: Quality-of-Life Assessment Drug: Systemic Chemotherapy Drug: Tamoxifen Citrate It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapy in treating patients with breast cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Estrogen can cause the growth of breast cancer cells. This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in the breast to surrounding normal tissue (invasive). Why Should I Register and Submit Results?.
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