2019
DOI: 10.1158/1538-7445.sabcs18-ot2-04-01
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Abstract OT2-04-01: Phase III trial to determine if chest wall and regional nodal radiotherapy (CWRNRT) post mastectomy (Mx) or the addition of RNRT to whole breast RT post breast-conserving surgery (BCS) reduces invasive breast cancer recurrence-free interval (IBCR-FI) in patients (pts) with pathologically positive axillary (PPAx) nodes who are ypN0 after neoadjuvant chemotherapy (NC): NRG Oncology/NSABP B-51/RTOG 1304

Abstract: This phase III post-NC trial evaluates if CWRNRT post-Mx or whole breast irradiation (WBI) with RNRT after BCS significantly reduces the IBCR-FI rate in pts with PPAx nodes that are pathologically negative after NC. Secondary aims are OS, LRR-FI, DR-FI, DFS-DCIS, second primary cancer, and comparison of RT effect on cosmesis in reconstructed Mx pts. Correlative science examines RT effect by tumor subtype, molecular outcome predictors for residual disease, and predictors for the degree of reduction in loco-regi… Show more

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Cited by 9 publications
(11 citation statements)
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“…[17][18][19][20] The risk of secondary angiosarcoma provides further impetus to not irradiate most people older than 65 years, given the lack of clinical benefit. There is also evidence that radiotherapy can be omitted for younger postmenopausal women at low risk for recurrence, 21,22 and additional trials are ongoing to further evaluate the possibility of de-escalation of breast radiotherapy. 23 Even though most patients with angiosarcoma present with localized disease, the extent of damage is often substantial, necessitating complex reconstructive surgery.…”
Section: Discussionmentioning
confidence: 99%
“…[17][18][19][20] The risk of secondary angiosarcoma provides further impetus to not irradiate most people older than 65 years, given the lack of clinical benefit. There is also evidence that radiotherapy can be omitted for younger postmenopausal women at low risk for recurrence, 21,22 and additional trials are ongoing to further evaluate the possibility of de-escalation of breast radiotherapy. 23 Even though most patients with angiosarcoma present with localized disease, the extent of damage is often substantial, necessitating complex reconstructive surgery.…”
Section: Discussionmentioning
confidence: 99%
“…Alternatively, the biopsied node can be clipped and retrieved at the time of SLN biopsy – the so-called targeted ALND ( 24 , 25 ). The ongoing NSABP B-51/RTOG 1304 and ATNEC trials will examine the role of RNI in ypN0 patients ( 26 , 27 ). The Dutch RAPCHEM;BOOG 2020-03 registry study is the first prospective evidence for the safety of selective de-escalation of radiation therapy after NACT for biopsy-proven clinically node positive T1-2N1 early breast cancers.…”
Section: Role Of Regional Radiotherapy In the Neo-adjuvant Eramentioning
confidence: 99%
“…This trial will determine whether SLN biopsy alone yields equivalent clinical outcomes to further axillary treatment (completion ALND or axillary irradiation) POSNOC has an in-built radiotherapy quality assurance programme coordinated by the UK Radiotherapy Trials Quality Assurance Group. The NSABP B-51/RTOG 1304 study will examine whether post-mastectomy radiotherapy combined with RNI or addition of RNI to breast RT following breast conserving surgery increases invasive breast cancer recurrence-free interval in cN1 patients converting to ypN0 after NACT ( 26 ). The ATNEC trial will randomize ypN0 patients to either observation only following SLN biopsy or further axillary treatment (completion ALND or axillary RT) ( 27 ).…”
Section: Concluding Commentsmentioning
confidence: 99%
“…More light on the feasibility of axillary de-escalation will be shed by ongoing phase III randomized trials in baseline cN+ patients undergoing PST followed by surgery including SLNB. The NSABP B-51/RTOG 1304 randomizes cT1-3pN1 patients who converted to ypN0 into RNI vs no RNI (NCT01872975) [74]. In the higher risk ypN+ population the ALLIANCE A011202 trial is evaluating omission of completion ALND in patients undergoing RNI (NCT01901094) [75].…”
Section: Tablementioning
confidence: 99%