Adult women over the age of 18 with invasive breast cancer with positive hormone receptors and 1-3 positive lymph nodes for a research study.
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less
Dillon Patrick, M
UVa Health System, Cancer Center, Division of Hematology/Oncology seeks adult women over the age of 18 with invasive breast cancer with positive hormone receptors and 1-3 positive lymph nodes for a research study. This study has two steps. Step 1 uses an FDA-approved test, called Oncotype DX®, on your breast cancer tumor to determine a score. If your score is eligible for Step 2, you may participate in the main study comparing 1 of 2 treatments. By chance, one group of participants will get standard types of hormone therapy, tamoxifen or aromatase inhibitor, for 5 to 10 years. The other group will get hormone therapy (tamoxifen or aromatase inhibitor) plus chemotherapy. You and your doctor will choose the best chemotherapy for you. In addition to treatment, study participants will have physician visits, blood draws and mammogram scans throughout the study. Because the treatment is selected by chance, you may have 3 to 12 study visits for chemotherapy treatments and/or 10 to 12 study visits for hormone therapy treatments, followed by 10 follow-up visits in the five years after treatment ends. Participant’s insurance company will be billed for all medication, tests and procedures. No compensation is provided for this study. Contact Information: For more information please contact: • Christina Taylor, RN • 434-243-0425 / firstname.lastname@example.org • IRB-HSR #15674 Principal Investigator: Patrick Dillon, MD