Abstract OT2-04-02: A phase 3 study of post-lumpectomy radiotherapy to whole breast + regional lymph nodes vs whole breast alone for patients with pN1 breast cancer treated with taxane-based chemotherapy (KROG 1701): Trial in progress

Abstract

Background In patients with early stage breast cancer, regional nodal irradiation (RNI) is added to whole breast irradiation (WBI) in order to control microscopic regional disease and to prevent systemic spread of cancer. According to recent randomized trials (MA.20 and EORTC 22922-10925), prophylactic RNI was associated with improvement in disease-free survival (DFS) in the patients with high-risk node negative or pN1 breast cancer. However, systemic agents now known to improve loco-regional control, such as taxane or endocrine therapy, were prescribed to a small percentage of patients in the studies. The benefit of RNI found in the previous studies might be attributed to incorporation of less effective systemic treatments. The impact of prophylactic RNI in pN1 breast cancer should be evaluated in the patients receiving modern systemic treatment. The current study was conducted to compare the effect of post-lumpectomy WBI vs WBI plus RNI on DFS in pN1 breast cancer patients who received adjuvant taxane-based chemotherapy. Methods This study is a multicenter, phase 3, randomized controlled non-inferiority trial (NCT03269981). Eligibility criteria are ≥ 20 years female; pathologically proven invasive carcinoma of the breast; one to three positive axillary lymph nodes (pN1) in pathologic specimen; receiving breast-conserving surgery followed by taxane-based chemotherapy; having adjuvant endocrine therapy or anti-HER2 treatment according to molecular subtype of tumor. Patients are randomly assigned in a 1:1 ratio to receive WBI or WBI plus RNI. Patient randomization was stratified by molecular subtype of tumor (i.e. luminal A/luminal B/luminal HER2/HER2-enriched/triple-negative) and methods of axillary management (i.e. sentinel lymph node biopsy/axillary lymph node dissection). The primary outcome is DFS. The secondary outcomes include DFS according to molecular subtype, treatment-related toxicity, and patient9s quality of life per EORTC QLQ-C30 and QLQ-BR23. Patients will be followed for survival and disease recurrence for seven years. A total of 1,926 patients are planned to be enrolled, with recruitment initiated in April 2017. As of June 2018, a total of 236 patients were enrolled. Acknowledgement This study was supported by a grant from the National RD 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr OT2-04-02.