Full TitleA Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chest Wall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy (NSABP B-51/RTOG 1304) (CIRB)(Protocol version 3, dated 24-FEB-2016)
In women with breast cancer that has not spread to the lymph nodes, radiation therapy is typically given to the affected breast in women who had a lumpectomy, and not at all in those who had a mastectomy. Women whose lymph nodes were found to contain cancer cells at the time of surgery also receive radiation therapy to the lymph nodes, to the breast (in the case of lumpectomy), and to the area of the chest wall where the breast was removed (for women who had a mastectomy).
In this study, researchers want to assess the value of giving radiation to the breast or chest wall as well as to the lymph nodes in women who had cancer cells in their lymph nodes at the time of breast cancer diagnosis, and whose lymph nodes were cleared of cancer cells by chemotherapy given before surgery. They want to see if this therapy helps women live longer, and also evaluate its effects on quality of life, particularly in women who had a mastectomy and breast reconstruction.
Women in this study will be randomly assigned to one of four treatments:
- Lumpectomy followed by radiation therapy to the affected breast alone
- Mastectomy followed by no radiation therapy
- Lumpectomy followed by radiation therapy to both the breast and affected lymph nodes
- Mastectomy followed by radiation therapy to the area of the chest where the breast used to be, as well as to the lymph nodes
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Participants in this study will include women who had chemotherapy before surgery for stage I-III breast cancer which cleared their lymph nodes of cancer cells, followed by lumpectomy or mastectomy.
- A biopsy must have shown that one to three lymph nodes contained cancer cells at the time of diagnosis, before the start of any treatment.
- No more than 56 days may pass between surgery or adjuvant chemotherapy and entry into the study.
- Patients may not have previously received radiation therapy to the breasts or chest.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for women age 18 and older.