- The NSABP B-51 / RTOG 1304 trial:
- Is a phase 3 randomized clinical trial currently accruing patients, which is designed to evaluate the role of regional nodal radiotherapy (RT) in patients who had documented positive axillary lymph nodes prior to undergoing NAC who subsequently convert to pathologically negative axillary nodes after the administration of NAC
- The primary endpoint is:
- To determine if regional nodal RT significantly reduces the rate of in-breast cancer recurrence free interval
- Node positivity will be documented by either FNA or core needle biopsy prior to the administration of NAC
- Patients will undergo standard NAC with the addition of anti-HER2 therapy for patients with HER2-positive tumors
- Patients can have either mastectomy or breast-conserving therapy
- Mastectomy patients will be randomized to:
- Either no RT or regional nodal RT and chest wall RT
- Breast conservation patients will be randomized to either whole-breast RT or whole-breast RT plus regional nodal RT
- A companion trial is being undertaken by The Alliance for Clinical Trials in Oncology:
- The A11202 trial is enrolling patients that were axillary node positive prior to NAC, have a normal axilla on physical exam after NAC, but have microscopic disease on sentinel lymph node biopsy
- This trial randomizes patients to completion axillary node dissection or sentinel lymph node biopsy only in addition to radiation therapy for both arms
- NSABP clinical trials overview. Protocol B-27. A randomized trial comparing preoperative doxorubicin (adriamycin) cyclophosphamide (ac) to preoperative ac followed by preoperative docetaxel (taxotere) and to preoperative ac followed by postoperative docetaxel in patients with operable carcinoma of the breast. National Surgical Adjuvant Breast and Bowel Project website. http://www.nsabp.pitt.edu/b-51.asp. Accessed May 15, 2020.
- NRG-alias protocol information. https://www.nrgoncology.org/Clinical-Trials/Protocol/nsabp-b-51-rtog-1304?filter=nsabp-b-51-rtog-1304. Accessed September 11, 2020.
- Comparison of axillary lymph node dissection with axillary radiation for patients with node-positive breast cancer treated with chemotherapy. NIH ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT01901094. Accessed May 15, 2020.
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