Abstract OT2-02-02: NRG Oncology/NSABP B-51/RTOG 1304: A phase III clinical trial to determine if chest wall and regional nodal radiotherapy (CWRNRT) post mastectomy (Mx) or the addition of RNRT to breast RT post breast-conserving surgery (BCS) will reduce invasive cancer events in patients (pts) with positive axillary (Ax) nodes who are ypN0 after neoadjuvant chemotherapy (NC)

Abstract

Background: This phase III post-NC trial will evaluate if CWRNRT post Mx or whole breast irradiation (WBI) with RNRT after BCS significantly reduces the invasive breast cancer recurrence-free interval (IBC-RFI) rate in pts presenting with positive Ax nodes that are negative after NC. Secondary aims are OS, LRRFI, DRFI, DFS-DCIS, and second primary cancer as well as comparing RT effect on cosmesis in reconstructed Mx pts. Correlative science examines RT effect by tumor subtype, molecular outcome predictors for residual disease pts, and predictors for the degree of reduction in loco-regional recurrence. Methods: Clinical T1-3, N1 IBC pts with positive Ax nodes (FNA or core needle biopsy) complete ≥12 wks of NC (anthracycline and/or taxane). HER2-positive pts receive anti-HER2 therapy (tx). After NC BCS or Mx is performed with a sentinel node biopsy (≥3 nodes) and/or Ax dissection with histologically negative nodes. ER/PR and HER-2 neu status before NC is required. Pts receive required systemic tx. Radiation credentialing with a facility questionnaire and a case benchmark is required. Randomization for Mx pts is to no CWRNRT or CWRNRT and for BCS pts to WBI or WBI RNRT. Statistics: 1,636 pts to be enrolled over 5 yrs with definitive analysis at 7.5 yrs. Study is powered at 80% to test that RT reduces the annual hazard rate of events for IBCR-FI by 35% for an absolute risk reduction in the 5-yr cumulative rate of 4.6%. Intent-to-treat analysis with 3 interim analyses at 43, 86, and 129 events, with a 4th/final analysis at 172 events will occur. Accrual as of 6/4/15 is 143. Pt-reported outcomes focusing on RT effect will be provided by 736 pts before randomization and at 3, 6, 12, and 24 months. Contacts: Protocol: CTSU member website https://www.ctsu.org. Questions: NRG Oncology Pgh Clin Coord Dpt: 1-800-477-7227 or ccd@nsabp.org. Pt entry: OPEN at https://open.ctsu.org or the OPEN tab on CTSU member website. Support: U10 CA-2166; -180868, -180822; -189867; Elekta. Citation Format: Mamounas EP, Bandos H, White JR, Julian TB, Khan AJ, Shaitelman SF, Torres MA, Vicini FA, Ganz PA, McCloskey SA, Paik S, Gupta N, Li XA, DiCostanzo DJ, Costantino JP, Curran Jr WJ, Wolmark N. NRG Oncology/NSABP B-51/RTOG 1304: A phase III clinical trial to determine if chest wall and regional nodal radiotherapy (CWRNRT) post mastectomy (Mx) or the addition of RNRT to breast RT post breast-conserving surgery (BCS) will reduce invasive cancer events in patients (pts) with positive axillary (Ax) nodes who are ypN0 after neoadjuvant chemotherapy (NC). [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr OT2-02-02.

Use of Three Dimensional Conformal Radiation Therapy for Node Positive Breast Cancer Does Not Result in Excess Lung and Heart Irradiation

“…In particular, recent breast cancer trails (e.g. NSABP B-51) have different heart goals for right and left sided WB/CW cases but our study used the same goals for both WB/CW cases [5]. However, the strengths of this study are that it is the first to our know-ledge to demonstrate in a large number of cases the feasibility of using dosevolume goals on DVHs to achieve an optimal 3DCRT treatment plan for NPBC.…”

“…Clinical delivery for breast treatment using 2DRT is still common despite two clinical trials demonstrating a reduction in acute and late adverse effects when using 3DCRT/IMRT compared to 2DRT [2] [3]. More recently, contouring atlases for breast have been developed and the use of dose-volume goals has become a standard element of RT planning for patients on more recent Radiation Therapy Oncology (RTOG) and National Surgical Adjuvant Breast and Bowel Project (NSABP) breast clinical trials [4] [5]. However, the uses of 3DCRT/IMRT with target and organs at risk (OAR) dose-volume goals for NPBC patients undergoing regional nodal irradiation after lumpectomy/mastectomy have yet to be standardized nor has the use of such goals gained widespread use in standard practice.…”