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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

Primary aim and endpoint Aim: To evaluate whether the addition of chestwall + regional nodal XRT after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly reduce the rate of events for invasive breast cancer recurrence-free interval (IBC-RFI) in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy. Endpoint: IBC-RFI, defined as time from randomization until invasive local, regional, or distant recurrence, or death from breast cancer. Secondary aims and endpoints Overall survival (OS) Aim: To evaluate whether the addition of chestwall + regional nodal XRT after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly prolong OS in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy. Endpoint: OS, defined as time from randomization to death from any cause. Loco-regional recurrence-free interval (LRRFI) Aim: To evaluate whether the addition of chestwall + regional nodal XRT after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly reduce the rates of events for LRRFI in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy. Endpoint: LRRFI, defined as the time from randomization to the recurrence of the primary breast cancer within the breast or in the lymph nodes in the ipsilateral axilla, infraclavicular fossa, or ipsilateral internal mammary chain without evidence of distant disease, or death due to breast cancer. Distant recurrence-free interval (DRFI) Aim: To evaluate whether the addition of chestwall + regional nodal XRT after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly reduce the rate of events for DRFI in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy. Endpoint: DRFI, defined as the time from randomization to the development of tumor in all areas beyond local or regional limits, or death due to breast cancer. Disease-free survival-ductal carcinoma in situ (DFS-DCIS) Aim: To compare the rates of DFS-DCIS by treatment arm. Endpoint: DFS-DCIS, defined as time from randomization to local recurrence following mastectomy, local recurrence in the ipsilateral breast following lumpectomy (invasive or DCIS), regional recurrence, distant recurrence, contralateral breast cancer (invasive or DCIS), second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer. Second primary invasive cancer Aim: To compare the rates of second primary invasive cancer by treatment arm. Endpoint: Second primary invasive cancer, defined as the time from randomization to the development of a second primary invasive cancer of any site excluding squamous and basal cell carcinoma of the skin. Quality of life Aim: To compare the effect of adding XRT on the cosmetic outcomes in mastectomy patients who have had reconstruction. Aim: To compare the effect of adding XRT on quality of life including arm problems, lymphedema, pain, and fatigue. Toxicity Aim: To evaluate the toxicity associated with each of the radiation therapy regimens. Endpoint: Frequencies of adverse events categorized using the NCI Common Terminology for Adverse Events Version 4.0 (CTCAE v4.0). **Please see more aims and endpoints in the protocol.

Primary aim and endpoint Aim: To evaluate whether the addition of chestwall + regional nodal XRT after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly reduce the rate of events for invasive breast cancer recurrence-free interval (IBC-RFI) in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy. Endpoint: IBC-RFI, defined as time from randomization until invasive local, regional, or distant recurrence, or death from breast cancer. Secondary aims and endpoints Overall survival (OS) Aim: To evaluate whether the addition of chestwall + regional nodal XRT after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly prolong OS in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy. Endpoint: OS, defined as time from randomization to death from any cause. Loco-regional recurrence-free interval (LRRFI) Aim: To evaluate whether the addition of chestwall + regional nodal XRT after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly reduce the rates of events for LRRFI in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy. Endpoint: LRRFI, defined as the time from randomization to the recurrence of the primary breast cancer within the breast or in the lymph nodes in the ipsilateral axilla, infraclavicular fossa, or ipsilateral internal mammary chain without evidence of distant disease, or death due to breast cancer. Distant recurrence-free interval (DRFI) Aim: To evaluate whether the addition of chestwall + regional nodal XRT after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly reduce the rate of events for DRFI in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy. Endpoint: DRFI, defined as the time from randomization to the development of tumor in all areas beyond local or regional limits, or death due to breast cancer. Disease-free survival-ductal carcinoma in situ (DFS-DCIS) Aim: To compare the rates of DFS-DCIS by treatment arm. Endpoint: DFS-DCIS, defined as time from randomization to local recurrence following mastectomy, local recurrence in the ipsilateral breast following lumpectomy (invasive or DCIS), regional recurrence, distant recurrence, contralateral breast cancer (invasive or DCIS), second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer. Second primary invasive cancer Aim: To compare the rates of second primary invasive cancer by treatment arm. Endpoint: Second primary invasive cancer, defined as the time from randomization to the development of a second primary invasive cancer of any site excluding squamous and basal cell carcinoma of the skin. Quality of life Aim: To compare the effect of adding XRT on the cosmetic outcomes in mastectomy patients who have had reconstruction. Aim: To compare the effect of adding XRT on quality of life including arm problems, lymphedema, pain, and fatigue. Toxicity Aim: To evaluate the toxicity associated with each of the radiation therapy regimens. Endpoint: Frequencies of adverse events categorized using the NCI Common Terminology for Adverse Events Version 4.0 (CTCAE v4.0). **Please see more aims and endpoints in the protocol.