Dr Shah on Research to Minimize Surgical Intervention in Locoregional Breast Cancer

Chirag Shah, MD, radiation oncologist, Department of Radiation Oncology, co-director, Comprehensive Breast Program, director, Clinical Research, director, Breast Radiation Oncology, Cleveland Clinic, discusses the clinical trials aiming to minimize surgical intervention in the treatment of patients with locoregional breast cancer.

Shah first highlights the recently published SOUND trial (NCT02167490), which investigated the possibility of omitting sentinel lymph node biopsies in patients with early-stage breast cancer who had a negative result on a preoperative axillary lymph node ultrasonography.. This trial, along with others, is aiming to identify subsets of patients who could safely undergo reduced surgical procedures without compromising outcomes. Findings from the trial showed that the omission of sentinel lymph node biopsy was noninferior in regard to distant disease-free survival (DDFS), with patients in the no auxiliary surgery group (n = 697) achieving a 5-year DDFS rate of 98.0% vs 97.7% for those who underwent sentinel lymph node biopsy (n = 708).

Shah also mentions that numerous trials are underway exploring reduction in radiation therapy for patients with early-stage breast cancer. He spotlights the ongoing phase 3 DEBRA trial (NCT04852887), which is utilizing the Oncotype DX assay to identify patients who may not require radiation therapy. The study is enrolling patients with hormone-sensitive, HER2-negative early-stage breast cancer who have an Oncotype recurrence score of 18 or less. Patients are being randomly assigned to receive endocrine therapy alone or endocrine therapy plus radiation following lumpectomy. This trial aims to personalize treatment plans based on genetic profiling, potentially sparing patients from unnecessary radiation and its associated toxicities, Shah says.

Shah also says Cleveland Clinic is participating in an ongoing phase 2 study (NCT06129747) examining the efficacy and safety of once-daily radiation therapy following repeat breast-conserving surgery.

Additionally, studies are addressing the need for lymph node radiation. Shah explains that the phase 3 CCTG MA.39 trial (NCT03488693), which is also leveraging the Oncotype DX assay, is examining the omission of regional radiotherapy in patients with biomarker low-risk, node-positive, T3N0 breast cancer.