NRG Oncology NSAPB B-51/RTOG 1304: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall 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

SUMMARY

You are being asked to take part in this study because you have had chemotherapy and then breast surgery to treat your breast cancer.  Before you received your chemotherapy, you had some cancer cells in your lymph nodes.  During the surgery that you had after finishing your chemotherapy, your doctor removed some lymph nodes from your underarm.  No cancer cells were found in any of the removed lymph nodes.

For women with breast cancer who do not have cancer cells in the lymph nodes removed at surgery, radiation is usually given to the breast only after lumpectomy and not at all after mastectomy.  For women with breast cancer who do have cancer cells in the lymph nodes removed at surgery, radiation is usually given to the breast and lymph nodes after lumpectomy; and after mastectomy, radiation is usually given to the area where the breast used to be and to the lymph nodes.

  • The main purpose of this clinical trial is to study women like you who have cancer cells in the lymph nodes at the time that the breast cancer is diagnosed and have chemotherapy before surgery that clears the cancer cells from the lymph nodes.  This study asks 1) if, after lumpectomy, radiation to the breast and lymph nodes will be better than radiation only to the breast at keeping breast cancer from returning, and 2) if, after mastectomy, radiation to the area where the breast used to be and to the lymph nodes is better than no radiation at keeping breast cancer from returning.
  • This study also asks whether giving radiation as described above will help women live longer.
    • In order to learn more about certain features of cancer tumors and how they respond to treatment, this study includes special research tests that will be done on samples of the tumor tissue.  The submission of tumor tissue from your breast biopsy and again at the time of your breast surgery, if any tumor remains in your breast, is a requirement of this study.  You cannot participate in this study if you do not agree to tumor submission.  Information about these study requirements will be explained to you in more detail later in this consent form.
    • This study will help researchers learn about how the study treatment affects your quality of life.  Quality of life is your physical and emotional well-being.  If you had a mastectomy and breast reconstruction (plastic surgery to restore the shape and appearance of your breast), the study also will learn about the feelings you have about how your breast looks after radiation therapy.  Researchers will compare your feelings to women who had a mastectomy and breast reconstruction but did not receive radiation therapy.  The study will also look at the quality of life issues related to arm function, arm and breast edema (swelling), breast appearance, pain, fatigue, and restricted work and social activity.

COH Protocol Number : 13327

ClinicalTrials.gov Number : NCT01872975

Principal Investigator : Lai, Lily M.D.

Sponsor : NRG Oncology

BRIEF ELIGIBILITY CRITERIA :

Eligible Ages : N/A

Prior Chemotherapy : Breast: Allowed

Brain Metastases :

Measurable Disease : Breast: Not Required