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About this trial

The purpose of this trial is to evaluate different radiotherapy treatments for patients with breast cancer 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.

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 after lumpectomy; and after mastectomy, radiation is usually given to the area where the breast used to be and to the lymph nodes. This trial asks firstly 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. Secondly 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.

The trial also asks whether giving radiation as described above will help women live longer.

Patient Profile

Patients must be female, over 18 years and must have early stage breast cancer with confirmed lymph node disease at the time of diagnosis (before neoadjuvant therapy). Patients will have hormone  receptor testing as part of their pre-treatment invesigations. This will influence if a patient will recieve hormone treatment. Patients will have HER-2(Human Epidermal Growth Factor Receptor 2) testing also which indicates if they recieve additional treatment for this.

Where’s this trial being run?

St Luke’s Radiation Oncology Network @ Beaumont Hospital, St Luke’s Radiation Oncology Network @ St James’s Hospital, St Luke’s Radiation Oncology Network @ St Luke’s Hospital, and University Hospital Galway

Can I join this study / trial?

The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.

Why not Print this page and bring it with you. It will help your doctor and research team advise you.

For more detailed information

Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Summary Data

Name: NSABP B-51
Number: 15-03
Full Title:

A Randomised 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.

Principal Investigator: Dr Joseph Martin (University Hospital Galway)
Type: Collaborative
Sponsor:

The study is being conducted by NRG Oncology. It was originally conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP) and the Radiation Therapy Oncology Group (RTOG). NSABP and RTOG have joined with one other clinical trials group to form NRG Oncology as required by the National Cancer Institute. Cancer Trials Ireland is sponsoring the study in Ireland.

Recruitment Started: Global: August 2013
Ireland: February 2016
Global Recruitment Target: 1636
Ireland Recruitment Target: Not specified