NCI CIRB# A011202 – Comparing Lymph Node Surgery vs. Radiation in Women with Breast Cancer

STUDY BASICS

Have you been diagnosed with breast cancer that has spread to the lymph nodes under your arm? Have you already been treated with chemotherapy? If so, you may be able to participate in a research study comparing surgery to radiation therapy.

STUDY PURPOSE

When breast cancer is initially diagnosed, finding cancer in the lymph nodes under the arm (in the armpit) increases the likelihood that cancer cells have spread to other parts of the body. Due to this increased risk, many women with this type of breast cancer undergo chemotherapy before surgery (also called neoadjuvant or preoperative chemotherapy) in an effort to shrink the cancer and allow for a less extensive surgery. Following chemotherapy, most women with this type of breast cancer go on to have surgery and radiation therapy in case any cancer cells remain. If cancer cells are found in any lymph nodes during the surgery, the surgeon will remove most of the lymph nodes under the arm. However, removing the lymph nodes can create complications including lymphedema (swelling in the arm) and problems with shoulder motion. The purpose of this study is to find out if having the surgery that involves removing most of the lymph nodes, followed by radiation therapy to the remaining areas, is as good as having radiation therapy directed to the lymph nodes and remaining areas. Researchers hope their findings may help some breast cancer patients in the future avoid extensive lymph node surgeries.

COULD THIS STUDY BE RIGHT FOR YOU?

• Women ages 18 and up
• Diagnosed with breast cancer that has spread to the lymph nodes under the arm
• Have already been treated with chemotherapy
• May or may not have already had surgery to remove the breast cancer and sample the lymph nodes

WHAT PARTICIPANTS CAN EXPECT

Participants will be randomly assigned (like the flip of a coin) to one of two groups. One group will have additional lymph nodes removed from under the arm, and the other group will not have additional lymph nodes removed. Participants in both groups will receive radiation therapy 5 days a week for 5-6 weeks. Participants will also have a physical examination every 6 months for the first 2 years, then every year for 3-5 years after your last radiation therapy treatment. If you had a lumpectomy (or partial mastectomy) to remove the breast cancer, you will have a mammogram of the breast that had the cancer once a year for 3-5 years after your last radiation therapy treatment